Kidney/Renal Cancer

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caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)


Condition: Metastatic Collecting Duct Renal Cell Carcinoma

Intervention:

  • Drug: Cabometyx

Purpose: This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic Collecting Duct Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03354884

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Primary Outcome Measures:

  • Measure: Objective response rate (ORR)
  • Time Frame: 30 Month
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression free Survival (PFS)
  • Time Frame: 30 Month
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: 30 Month
  • Safety Issue:
  • Measure: Safety and Tolerability (Adverse Events)
  • Time Frame: 30 Month
  • Safety Issue:

Estimated Enrollment: 23

Study Start Date: January 12, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 85 Years
  • Gender: All

Inclusion Criteria:

  • 1. Written Informed Consent Form 2. Unresectable, advanced or metastatic collecting ducts carcinoma untreated with any systemic agent for advanced disease 3. Measurable disease as defined by RECIST v1.1 criteria 4. Age ≥18 years 5. ECOG Performance Status 0-1 6. Any of the following laboratory test findings:
  • Hemoglobin > 9 g/dL (5.6 mmol/L)
  • WBC > 2,000/mm3
  • Neutrophils > 1,500/mm3
  • Platelets > 100,000/mm3
  • AST or ALT < 3 x ULN (< 5 x ULN if liver metastases are present)
  • Total Bilirubin < 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
  • Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min (measured or calculated by Cockroft-Gault formula)
  • Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis
  • PT-INR/PTT ≤ 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care 7. Availability of a representative FFPE tumor specimen collected within 24 months of starting first-line cabozantinib that enables the definitive diagnosis of CDC (the archival specimen must contain adequate viable tumor tissue to enable candidate biomarkers status; the specimen may consist of a tissue block or at least 15 unstained serial sections; for core needle biopsy specimens, at least two cores should be available for evaluation) 8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and for 4 months after the last dose of study treatment 9. Female subjects of childbearing potential must not be pregnant at screening

Exclusion Criteria:

  1. Previous therapy for advanced disease; any medical adjuvant treatment must have been stopped at least six months before entry into the study
  2. History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  3. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
  4. History of cerebrovascular accidents, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  5. Major surgery or trauma within 28 days before to study entry; the such as catheter placement not considered to be major surgery).
  6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization.
  7. Evidence of active bleeding or bleeding diathesis and/or clinically-significant GI bleeding within 6 months before the first dose of study treatment; 3 months for pulmonary hemorrhage and patients with tumor invading or encasing any major blood vessels.
  8. Patients with GI disorders associated with a high risk of perforation or fistula formation.
  9. Subjects with clinically relevant ongoing complications from prior radiation therapy.
  10. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  11. Previous or ongoing treatment (except for adjuvant therapies) with any of the following anti-cancer therapies: chemotherapy, immunotherapy, target therapies, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Cabozantinib
  12. Inability to swallow tablets or capsules.

Contact:

  • Giuseppe Procopio, MD
  • +390223904450

Location:

  • Giuseppe Procopio
  • Milan 20133 Italy

View trial on ClinicalTrials.gov


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A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy


Condition: Advanced Renal Cell Carcinoma

Intervention:

  • Drug: Cabozantinib

Purpose: The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese patients with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03339219

Sponsor: Takeda

Primary Outcome Measures:

  • Measure: Objective Response Rate (ORR)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Clinical Benefit Rate (CBR)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Progression-Free Survival (PFS)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Grade 3 or Higher TEAEs
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Serious TEAEs
  • Time Frame: Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with TEAEs Leading to Permanent Treatment Discontinuation
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
  • Time Frame: Baseline up to 3 years (approximately 2 years after enrollment of the last participant)
  • Safety Issue:
  • Measure: Percentage of Participants with Clinically Significant Abnormal Laboratory Values
  • Time Frame: Up to approximately 2 years after enrollment of the last participant
  • Safety Issue:
  • Measure: Percentage of Participants with Clinically Significant Abnormal Vital Sign Measurements
  • Time Frame: Up to approximately 2 years after enrollment of the last participant
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: November 13, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 20 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Male or female Japanese patients 20 years of age or older on the day of consent.
  • Documented histological or cytological diagnosis of RCC with a clear-cell component.
  • Measurable disease per RECIST 1.1 as determined by the investigator.
  • Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
  • For the most recently received VEGFR-targeting TKI the following criteria must apply:
  • Must have radiographically progressed during treatment, or been treated for at least 4 weeks and radiographically progressed within 6 months after the last dose. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator on computerized tomography (CT) or magnetic resonance imaging (MRI) scans.
  • The last dose must have been within 6 months before the first day of study drug administration (Week 1 Day 1).
  • Recovery to baseline or ≤Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Karnofsky Performance Status (KPS) score of ≥70%.
  • Adequate organ and marrow function at Screening.

Exclusion Criteria:

  • Prior treatment with everolimus, or any other specific or selective target of rapamycin complex 1 /phosphoinositide 3-kinase/AKT inhibitor (eg, temsirolimus), or cabozantinib.
  • Receipt of any type of small-molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before Week 1 Day 1.
  • Receipt of any type of anticancer antibody (including investigational antibody) within 28 days before Week 1 Day 1.
  • Radiation therapy for bone metastasis within 14 days, and/or any other external radiation therapy within 28 days before Week 1 Day 1. Systemic treatment with radionuclides within 42 days before Week 1 Day 1. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Contact:

  • Takeda Study Registration Call Center
  • +1-877-825-3327

Locations:

  • Nagoya University Hospital
  • Nagoya Aichi Japan
  • Hokkaido University Hospital
  • Sapporo Hokkaido Japan
  • Sapporo Medical University Hospital
  • Sapporo Hokkaido Japan
  • Kobe University Hospital
  • Kobe Hyogo Japan
  • Yokohama City University Hospital
  • Yokohama Kanagawa Japan
  • Yokohama City University Medical Center
  • Yokohama Kanagawa Japan
  • Kindai University Hospital
  • Osakasayama Osaka Japan
  • Osaka University Hospital
  • Suita Osaka Japan
  • Nippon Medcal School Hospital
  • Bunkyo-ku Tokyo Japan
  • Toranomon Hospital
  • Minato-ku Tokyo Japan
  • Keio University Hospital
  • Shinjuku-ku Tokyo Japan
  • Tokyo Women's Medical University Hospital
  • Shinjuku-ku Tokyo Japan
  • Kyushu University Hospital
  • Fukuoka Japan
  • Niigata University Medical and Dental Hospital
  • Niigata Japan
  • Okayama University Hospital
  • Okayama Japan
  • Osaka City University Hospital
  • Osaka Japan
  • Osaka International Cancer Institute
  • Osaka Japan
  • Tokushima University Hospital
  • Tokushima Japan
  • Yamagata University Hospital
  • Yamagata Japan

View trial on ClinicalTrials.gov


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A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Intervention:

  • Biological: Nivolumab
  • Drug: Cabozantinib
  • Drug: Sunitinib
  • Biological: Ipilimumab

Purpose: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03141177

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Progression Free Survival (PFS) per blinded independent central review (BICR)
  • Time Frame: Up to 21 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: Up to 64 months
  • Safety Issue:
  • Measure: Objective Response Rate (ORR)
  • Time Frame: Approximately 16 months
  • Safety Issue:
  • Measure: Incidence of adverse events (AEs)
  • Time Frame: Up to 64 months
  • Safety Issue:
  • Measure: Incidence of Serious Adverse Events (SAEs)
  • Time Frame: Up to 64 months
  • Safety Issue:

Estimated Enrollment: 630

Study Start Date: July 11, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria:
  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/

Exclusion Criteria:

  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Southern Cancer Center, Inc.
  • Daphne Alabama 36526 United States
  • Cancer Treatment Centers of America-Western
  • Goodyear Arizona 85338 United States
  • CBCC Global Research, Inc.
  • Bakersfield California 93309 United States
  • Local Institution
  • Los Angeles California 90017 United States
  • UCLA Hematology Oncology
  • Los Angeles California 90095 United States
  • Cancer Care Associates Medical Group, Inc.
  • Redondo Beach California 90277 United States
  • Coastal Integrative Cancer Care
  • San Luis Obispo California 93401 United States
  • Central Coast Med Oncology
  • Santa Maria California 93454 United States
  • University Of Colorado Cancer Center
  • Aurora Colorado 80045 United States
  • University Cancer Blood Ctr
  • Athens Georgia 30607 United States
  • Southeastern Regional Medical Center - CTCA
  • Newnan Georgia 30265 United States
  • Local Institution
  • Chicago Illinois 60612 United States
  • Midwestern Regional Medical Center
  • Zion Illinois 60099 United States
  • Ft. Wayne Med Onco-Hema Inc
  • Fort Wayne Indiana 46845 United States
  • Cancer Center Of Kansas
  • Wichita Kansas 67214 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Local Institution
  • Boston Massachusetts 02215 United States
  • University Of Michigan
  • Ann Arbor Michigan 48109 United States
  • HCA Midwest Division
  • Kansas City Missouri 64132 United States
  • Washington University School Of Medicine
  • Saint Louis Missouri 63110 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89169 United States
  • Local Institution
  • Buffalo New York 14263 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Local Institution
  • Cincinnati Ohio 45230 United States
  • Local Institution
  • Portland Oregon 97239 United States
  • Lehigh Valley Health Network
  • Allentown Pennsylvania 18103 United States
  • Tennessee Oncology, PLLC
  • Nashville Tennessee 37203 United States
  • Texas Oncology
  • Austin Texas 78731 United States
  • Baylor Sammons Cancer Center
  • Dallas Texas 75246 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Local Institution
  • Midland Texas 79701 United States
  • Local Institution
  • Plano Texas 75093 United States
  • Texas Cancer Center - Sherman
  • Sherman Texas 75090 United States
  • Local Institution
  • Salt Lake City Utah 84112 United States
  • Virginia Oncology Associates
  • Norfolk Virginia 23502 United States
  • Local Institution
  • Seattle Washington 98195 United States
  • Hospital Italiano De Buenos Aires
  • Ciudad Autonoma De Buenos Aire Buenos Aires 1181 Argentina
  • Local Institution
  • Córdoba Cordoba 5016 Argentina
  • Clinica Viedma S.A.
  • Viedma RIO Negro 8500 Argentina
  • Centro Medico San Roque
  • San Miguel De Tucuman Tucuman Argentina
  • Centro De Diagnostico Urologico S.R.L.
  • Buenos Aires 1120 Argentina
  • Local Institution
  • Caba 1426 Argentina
  • Instituto Oncologico De Cordoba
  • Cordoba 5000 Argentina
  • Local Institution
  • Cordoba X5004FHP Argentina
  • Local Institution
  • Darlinghurst New South Wales 2010 Australia
  • Local Institution
  • North Ryde New South Wales Australia
  • Local Institution
  • Sydney New South Wales 2139 Australia
  • Local Institution
  • Westmead New South Wales 2145 Australia
  • Local Institution
  • Herston Queensland 4006 Australia
  • Local Institution
  • South Brisbane Queensland 4101 Australia
  • Tasman Oncology Research Pty Ltd
  • Southport Queensland 4215 Australia
  • Local Institution
  • Elizabeth Vale South Australia 5112 Australia
  • Local Institution
  • Malvern Victoria 3144 Australia
  • Local Institution
  • Doubleview Western Australia 6018 Australia
  • Local Institution
  • Belo Horizonte Minas Gerais 30130-090 Brazil
  • Local Institution
  • Ijui RIO Grande DO SUL 98700-000 Brazil
  • Local Institution
  • Porto Alegre RIO Grande DO SUL 90610-000 Brazil
  • Local Institution
  • Porto Alegre RIO Grande DO SUL 91350-200 Brazil
  • Local Institution
  • Barretos SAO Paulo 14784-400 Brazil
  • Local Institution
  • S?o Paulo SAO Paulo 05651-901 Brazil
  • Local Institution
  • Rio De Janeiro 20231-050 Brazil
  • Local Institution
  • Sao Paulo 01323-020 Brazil
  • Centro Internacional de Estudios Clinicos
  • Recoleta Santiago DE Chile Chile
  • Klinika onkologie a radioterapie
  • Hradec Kralove 500 05 Czechia
  • Onkologicka klinika
  • Olomouc 779 00 Czechia
  • Local Institution
  • Bordeaux 33075 France
  • Local Institution
  • Caen 14000 France
  • Local Institution
  • Lyon Cedex 08 69373 France
  • Local Institution
  • Marseille Cedex 9 13009 France
  • Local Institution
  • Montpellier Cedex 34295 France
  • Local Institution
  • Nantes 44202 France
  • Local Institution
  • Paris 75015 France
  • Local Institution
  • Strasbourg Cedex 67091 France
  • Local Institution
  • Toulouse 31100 France
  • Local Institution
  • Villejuif 94805 France
  • Universitaetsklinikum Aachen
  • Aachen 52074 Germany
  • Universitaetsklinikum Bonn
  • Bonn 53127 Germany
  • Klinik Essen-Mitte
  • Essen 45136 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Klinikum Rechts Der Isar Der Tum
  • Muenchen 81675 Germany
  • Klinikum Nuernberg Nord, Urologische Klinik
  • Nuernberg 90419 Germany
  • Uniklinik Tuebingen
  • Tuebingen 72076 Germany
  • Local Institution
  • Athens 11528 Greece
  • Local Institution
  • Thessaloniki 54645 Greece
  • Local Institution
  • Haifa 3109601 Israel
  • Local Institution
  • Kfar Saba 44281 Israel
  • Local Institution
  • Petah Tikva 49414 Israel
  • Local Institution
  • Ramat Gan 52621 Israel
  • Local Institution
  • Arezzo 52100 Italy
  • Local Institution
  • Milano 20132 Italy
  • Local Institution
  • Napoli 80131 Italy
  • Local Institution
  • Padova Padova Italy
  • Local Institution
  • Pavia 27100 Italy
  • Comite Mexicano para la Prevenion de la Osteoporosis A.C.
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
  • Mexico Distrito Federal 14080 Mexico
  • Local Institution
  • Tlalpan Distrito Federal 14080 Mexico
  • Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.
  • Zapopan Jalisco 45030 Mexico
  • Local Institution
  • Monterrey Nuevo LEON 64000 Mexico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Monterrey Nuevo LEON 64460 Mexico
  • Merida Investigacion Clincia
  • Merida Yucatan 97125 Mexico
  • Local Institution
  • Monterrey, NL 64060 Mexico
  • Hospital Medica Tec 100
  • Queretaro 76000 Mexico
  • Local Institution
  • Biala Podlaska 21-500 Poland
  • Ambulatorium Chemioterapii
  • Bydgoszcz 85-796 Poland
  • Wojewodzkie Centrum Onkologii
  • Gdansk 80-19 Poland
  • Local Institution
  • Cluj Napoca 400015 Romania
  • Local Institution
  • Craiova 200347 Romania
  • Local Institution
  • Moscow 115478 Russian Federation
  • Local Institution
  • Moscow 117997 Russian Federation
  • Local Institution
  • Moscow 125284 Russian Federation
  • Local Institution
  • Nizhniy Novgorod 603109 Russian Federation
  • Local Institution
  • Saint-Petersburg 197758 Russian Federation
  • Local Institution
  • A Coru?a 15006 Spain
  • Local Institution
  • Barcelona 08035 Spain
  • Local Institution
  • Madrid 28009 Spain
  • Local Institution
  • Madrid 28041 Spain
  • Local Institution
  • Santander 39008 Spain
  • Local Institution
  • Sevilla 41013 Spain
  • Local Institution
  • Valencia 46014 Spain
  • Local Institution
  • Ankara 06018 Turkey
  • Local Institution
  • Ankara 06590 Turkey
  • Local Institution
  • Ankara 06800 Turkey
  • Local Institution
  • Antalya 07070 Turkey
  • Local Institution
  • Denizli 20070 Turkey
  • Local Institution
  • Edirne 22100 Turkey
  • Local Institution
  • London Greater London EC1A 7BE United Kingdom
  • Local Institution
  • Manchester Greater Manchester M20 4BX United Kingdom
  • Local Institution
  • Newcastle Upon Tyne NE7 7DN United Kingdom
  • Local Institution
  • Truro TR1 3LJ United Kingdom

View trial on ClinicalTrials.gov


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Phase I/II Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma


Condition: Metastatic Renal Cell Carcinoma

Intervention:

  • Drug: Cabozantinib
  • Drug: Pembrolizumab

Purpose: This study is designed to evaluate the combination of pembrolizumab and cabozantinib in subjects with locally advanced, recurrent, or metastatic renal cell carcinoma that has progressed after treatment with at least one prior VEGF-targeted therapy, or for whom VEGF-targeted therapy has proven to be intolerable, or is considered inappropriate.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03149822

Sponsor: University of Colorado, Denver

Primary Outcome Measures:

  • Measure: Objective Response Rate
  • Time Frame: 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Maximally Tolerated Dose (MTD) of pembrolizumab and cabozantinib
  • Time Frame: Up to Cycle 2 of Phase 1 (21 days)
  • Safety Issue:
  • Measure: Recommended Phase 2 Dose
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Progression-free survival
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 55

Study Start Date: September 28, 2017

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: All

Inclusion Criteria:

  • Presence of locally advanced or metastatic renal cell carcinoma that has progressed after treatment with at least one prior VEGF-targeted therapy, or for whom VEGF-targeted therapy has proven to be intolerable, or is considered inappropriate.
  • Measurable or evaluable disease based on RECIST 1.1.
  • Availability of archival tumor specimen
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate organ function as defined in the protocol.

Exclusion Criteria:

  • Prior study anti-cancer therapies or anti-cancer monoclonal antibody within 4 weeks of the study Day 1.
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
  • History of immunodeficiency or current systemic steroid therapy equivalent to ≥ 10 mg/day of prednisone.
  • Known history of active TB (Bacillus Tuberculosis)
  • Prior treatment with pembrolizumab.
  • Prior treatment with cabozantinib.
  • Prior treatment with immune checkpoint inhibitors is allowed provided that no treatment-related Grade ≥ 3 adverse events were observed and at least a minimum of 28 days have elapsed between the last dose of prior treatment and the proposed Cycle 1 Day 1.
  • Known additional malignancy that is progressing or requires active treatment.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • History of solid organ transplantation.
  • History of osteonecrosis of the jaw.
  • History of reversible posterior leukoencephalopathy syndrome.
  • History of wound dehiscence or complications requiring medical intervention within 6 months of study entry.
  • History of (non-infectious) pneumonitis that required steroids or active, non-infectious pneumonitis.
  • Active infection requiring systemic therapy.
  • Uncontrolled, significant intercurrent or recent illness
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Pregnant or breastfeeding.
  • Inability to swallow tablets or capsules.
  • History of Human Immunodeficiency Virus (HIV).
  • Active Hepatitis B or Hepatitis C.
  • Received a live vaccine within 30 days of planned start of study therapy.

Contact:

  • Meghan O'Leary-Kelly
  • 720-848-0602

Location:

  • University of Colorado Denver
  • Aurora Colorado 80045 United States

View trial on ClinicalTrials.gov


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A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA


Condition: Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Intervention:

  • Drug: CB-839
  • Drug: Cabozantinib
  • Drug: Placebo

Purpose: This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03428217

Sponsor: Calithera Biosciences, Inc

Primary Outcome Measures:

  • Measure: Progression Free Survival (PFS)
  • Time Frame: 18 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival (OS) of study patients treated with CB-Cabo vs Pbo-Cabo
  • Time Frame: 36 months
  • Safety Issue:
  • Measure: PFS of patients treated with CB-Cabo vs Pbo-Cabo
  • Time Frame: 18 months
  • Safety Issue:

Estimated Enrollment: 298

Study Start Date: March 27, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
  • Adult patients
  • Karnofsky Performance Score (KPS) ≥ 70%
  • Measurable Disease per RECIST 1.1
  • 1-2 lines of prior therapy for advanced or metastatic RCC including at least one antiangiogenic therapy or nivolumab + ipilimumab
  • Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

  • Prior treatment with cabozantinib (or other MET inhibitor) or CB-839
  • Receipt of other anticancer therapy within 2
  • 6 weeks, depending on the treatment
  • Untreated or active brain metastases or central nervous system cancer, as defined per protocol
  • Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
  • Known active infection with HIV, Hepatitis B or C virus
  • Requirement for continued proton pump inhibitor after randomization

Contact:

  • Clinical Trials Administrator
  • 650-870-1000

Locations:

  • Penrose Research Department
  • Colorado Springs Colorado 80907 United States
  • Georgetown University Medical Center
  • Washington District of Columbia 20007 United States
  • Georgia Cancer Center at Augusta University
  • Augusta Georgia 30912 United States
  • Northwest Georgia Oncology Centers, PC
  • Marietta Georgia 30060 United States
  • Goshen Center for Cancer Care
  • Goshen Indiana 46526 United States
  • East Jefferson General Hospital
  • Metairie Louisiana 70006 United States
  • Hattiesburg Clinic Hematology/Oncology
  • Hattiesburg Mississippi 39401 United States
  • San Juan Oncology Associates, PC
  • Farmington New Mexico 87401 United States
  • North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists
  • East Setauket New York 11733 United States
  • NYU Winthrop Hospital
  • Mineola New York 11501 United States
  • Northern Westchester Hospital
  • Mount Kisco New York 10549 United States
  • Stony Brook Cancer Center
  • Stony Brook New York 11794 United States
  • Saint Francis Hospital Cancer Center
  • Greenville South Carolina 29607 United States
  • West Cancer Center
  • Germantown Tennessee 38138 United States
  • MD Anderson
  • Houston Texas 77030 United States
  • University of Utah, Huntsman Cancer Institute
  • Salt Lake City Utah 84112 United States
  • Kadlec Clinic Hematology and Oncology
  • Kennewick Washington 99336 United States

View trial on ClinicalTrials.gov


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Cabosun II: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma


Condition: Malignant Neoplasms of Urinary Tract, Renal Cell Carcinoma

Intervention:

  • Drug: Cabozantinib
  • Drug: Sunitinib

Purpose: The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer. This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC. The study doctor can explain how the study drugs are designed to work. Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03541902

Sponsor: M.D. Anderson Cancer Center

Primary Outcome Measures:

  • Measure: Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria
  • Time Frame: From randomization up to the time of disease progression or death up to two years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response Rate (ORR) Evaluated Using RECIST 1.1 Criteria
  • Time Frame: From randomization up to the time of disease progression or death up to two years
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: From randomization to death or last contact if still alive up to two years
  • Safety Issue:
  • Measure: Adverse Event Rates
  • Time Frame: Start of study drug up to 30 days after last dose of study drug
  • Safety Issue:

Estimated Enrollment: 84

Study Start Date: May 15, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. The subject has a histologic or cytologic diagnosis of a variant histology renal cell carcinoma including papillary, chromophobe, Xp.11 translocation, undifferentiated, or unclassified which is treatment naïve or has previously been treated with one systemic treatment line not containing any vascular endothelial growth factor antibody or vascular endothelial growth factor receptor tyrosine kinase inhibitors. The patient may have received treatment with immune checkpoint therapy including nivolumab as a single agent or nivolumab plus ipilimumab in combination. Previous treatment with mammalian target of rapamycin agents such as temsirolimus or everolimus is acceptable. 2. Measurable disease per RECIST v1.1 as determined by the investigator. 3. The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib or sunitinib. 4. The subject is >/=18 years old on the day of consent; 5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of /= 1500/mm^3 without colony stimulating factor support; b.White blood cell count >/= 2500/mm^3 (>/= 2.5 GI/L). c.Platelets >/=100,000/mm^3; d.Hemoglobin >/= 9 g/dL; e. Bilirubin /= 2.8 g/dl g.Serum creatinine /= 30 mL/min (>/= 0.5 mL/sec) using the Cockcroft-Gault equation: Males: (140
  • age) x weight (kg)/(serum creatinine [mg/dL] × 72) Females: [(140
  • age) x weight (kg)/(serum creatinine [mg/dL] × 72)] × 0.85 h.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP)

Exclusion Criteria:

  1. The subject has a variant histology that includes renal medullary carcinoma or collecting duct renal cell carcinoma. Any clear cell component in the tumor will lead to exclusion.
  2. The subject has received any previous anti-angiogenic agent. Prior treatment with cabozantinib.
  3. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible;
  4. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment;
  5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment;
  6. Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following: Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted. Low-dose low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  7. The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) tes>/=1.3 X the laboratory ULN within 7 days before the first dose of study treatment.
  8. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: a.Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. b.Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment. c.Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose.
  9. Continuation of 8:Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.
  10. Continuation of 8: Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. Lesions invading or encasing any major blood vessels. Other clinically significant disorders that would preclude safe study participation. Serious non-healing wound/ulcer/bone fracture. Uncompensated/symptomatic hypothyroidism. Moderate to severe hepatic impairment (Child-Pugh B or C).
  11. Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  12. Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment
  13. Pregnant or lactating females.
  14. Inability to swallow tablets
  15. Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  16. Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Patients with Gleason 6 (3+3) prostate cancer with previous treatment or on active surveillance may also be allowed on protocol.
  17. The subject requires chronic concomitant treatment with strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's Wort).

Contact:

  • Matthew Campbell, MD
  • 713-792-2830

Locations:

  • University of Texas MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • MD Anderson Katy Regional Care Center
  • Houston Texas 77094 United States
  • MD Anderson Sugarland Regional Care Center
  • Sugar Land Texas 77478 United States

View trial on ClinicalTrials.gov


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Prospective Non Interventional Study of Cabozantinib Tablets in Adults With Advanced Renal Cell Carcinoma Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy


Condition: Renal Cell Carcinoma

Intervention:

  • Other: Data collection

Purpose: The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03419572

Sponsor: Ipsen

Primary Outcome Measures:

  • Measure: The proportion of subjects with dose modifications due to AEs
  • Time Frame: 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Description of cabozantinib starting dose (combination of dose per intake and frequency)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Description of daily dose of cabozantinib received
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Description of cabozantinib dose intensity (average daily dose compared to starting dose)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Proportion of subjects with concomitant radiotherapies
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Description of systemic therapy (drug name) planned following cabozantinib discontinuation
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Overall best response
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Median Progression Free Survival (PFS) time
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Overall Survival (OS) rate at the end of the study
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Health care resource utilisation: number of visits to health care professionals (hospitalisation, surgical procedure, emergency room, physician, homecare by nurse) associated with the management of treatment-related AEs
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs
  • Time Frame: 12 months
  • Safety Issue:

Estimated Enrollment: 680

Study Start Date: April 24, 2018

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age ≥18 years old
  • Has a diagnosis of advanced RCC
  • Has received at least one prior VEGF-targeted therapy
  • For whom the treating physician has decided to start treatment with cabozantinib tablets prior to inclusion
  • No previous exposure to cabozantinib prior to inclusion
  • Not concurrently involved in an interventional study
  • Consents to participate in this noninterventional study Exclusion Criteria:
  • There are no

Exclusion Criteria:

  • There are no exclusion criteria for this study.

Contact:

  • Ipsen Recruitment Enquiries

Locations:

  • Klinikum Augsburg, II Medizinische Klinik, Hamatologie/Onkologie
  • Augsburg 86156 Germany
  • Charité - Universitätsmedizin Berlin
  • Berlin 12200 Germany
  • Vivantes Klinikum Neukolln
  • Berlin 12351 Germany
  • University Heidelberg
  • Heidelberg 69120 Germany
  • University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15
  • München 81377 Germany
  • Universitätsklinikum Münster
  • Münster D-48149 Germany
  • University Medical Center Ulm
  • Ulm 89075 Germany
  • Franciscus Gasthuis
  • Rotterdam 3045 PM Netherlands
  • Hospital Vall Hebron
  • Barcelona 8035 Spain
  • Hosptial Clinic de Barcelona
  • Barcelona 8036 Spain
  • Hospital Universitario de León
  • León 24080 Spain
  • Hospital 12 de Octubre
  • Madrid 28041 Spain
  • Hospital Universitari Parc Tauli
  • Sabadell 8208 Spain
  • East and North Hertfordshire
  • Northwood HA6 2RN United Kingdom

View trial on ClinicalTrials.gov


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