Bladder Cancer

Condition: Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02783300

Sponsor: GlaxoSmithKline

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

• Males and females greater than or equal to (>=)18 years of age (at the time consent is obtained)
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
• Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL
• Presence of evaluable disease
• Adequate organ function (as defined in the protocol)
• Reproductive criteria (as defined in the protocol).

Exclusion Criteria:

• Malignancy attributed to prior solid organ transplant
• Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example [e.g.], for symptomatic disease)
• History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years
• Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
• Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
• Select cardiac abnormalities (as defined in the protocol)
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
• History of optic nerve neuropathy or neuritis.

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Condition: Localized Renal Pelvis and Ureter Urothelial Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Soft Tissues, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, Recurrent Bladder Carcinoma, Recurrent Prostate Carcinoma, Recurrent Renal Pelvis and Ureter Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v7, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage IV Prostate Cancer AJCC v7

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01050504

Sponsor: University of Washington

Phase:

Eligibility:

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

Inclusion Criteria:

• Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
• Ability to adequately understand and give informed consent
• Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study
• Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured
• Platelet count > 50,000
• White blood cell (WBC) > 1,500
• Hemoglobin (Hgb) > 8.0
• International normalized ratio (INR) < 1.5
• Partial thromboplastin time (PTT) < 45
• No history of excessive unexplained bleeding from previous surgery

Exclusion Criteria:

• Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days
• Serious or uncontrolled infection
• Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days

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Condition: Urothelial Cancer, Renal Pelvis Cancer, Ureter Cancer, Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00902590

Sponsor: Memorial Sloan Kettering Cancer Center

Phase:

Eligibility:

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

Inclusion Criteria:

• Urothelial Cancer Cases
• Must be ≥ 18 years of age AND
• Must have a diagnosis of urothelial cancer AND
• Must be an English-speaker Non-Cancer Control Group
• Must be ≥ 18 years of age AND
• Must not have cancer or a personal history of cancer, with the exception of skin cancer. AND
• Must not be a blood relative of cases AND
• Must not be a blood relative of another control AND
• Must be an English-speaker Family Member Control Group: In select kindreds with a high prevalence of bladder cancer and/or very early onset bladder cancer, first- and second-degree family members of probands may be contacted by the MSKCC study team and invited to complete the questionnaire and submit a saliva sample.
• Must be ≥ 18 years of age AND
• Must be a blood relative of a case participant AND
• Must be an English-speaker

Exclusion Criteria:

• Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent.

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Condition: Urothelial Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03390504

Sponsor: Janssen Research & Development, LLC

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
• Metastatic or surgically unresectable urothelial cancer
• Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
• Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.
• A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)
• Participants must meet appropriate molecular

Eligibility Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
• Adequate bone marrow, liver, and renal function

Exclusion Criteria:

• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
• Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.
• Symptomatic central nervous system metastases
• Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
• Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
• Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.
• History of uncontrolled cardiovascular disease
• Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions

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