Condition: Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases

Intervention:

• Drug: Vofatamab
• Drug: Docetaxel
• Drug: Placebo

Purpose: This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02401542

Sponsor: Rainier Therapeutics

Primary Outcome Measures:

• Measure: Primary Efficacy Outcome: Progression Free Survival (PFS)
• Time Frame: 3-4 years
• Safety Issue:

Secondary Outcome Measures:

• Measure: Secondary Efficacy Outcome: Overall Survival (OS)
• Time Frame: up to 3-4 years
• Safety Issue:
• Measure: Efficacy Outcome - Objective Response Rate (ORR)
• Time Frame: up to 3-4 years
• Safety Issue:

Estimated Enrollment: 300

Study Start Date: June 2015

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

1. Stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or TCC arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
2. Histological or cytological diagnosis of UCC.
3. Relapsed after or are refractory to at least one prior line of chemotherapy which has not included a taxane (with the exception of Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion of Phase 2b which will allow the enrollment of patients with prior treatment with a taxane)
4. Subjects must have received at least one prior chemotherapeutic regimen (at least one cycle each) for advanced or metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated).
5. Prior neoadjuvant or adjuvant chemotherapy (without a taxane, except Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion, which will allow the enrollment of subjects with prior treatment with a taxane) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose.
6. Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Phase 2 and Phase 2b Specific Inclusion Criteria:
7. Patient must be confirmed to have a FGFR3 genomic alteration at the time of documentation of advanced disease.
8. Relapsed after or are refractory to an immune checkpoint inhibitor. This inclusion criterion does not apply if the checkpoint inhibitor is contraindicated. Main

Exclusion Criteria:

• Prior anti-cancer therapy within 2 weeks prior to Cycle 1, Day 1
• Prior treatment with an inhibitor that is targeted primarily to FGFRs
• Clinically significant comorbid medical conditions or lab abnormalities
• History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months
• History of clinically significant coagulation or platelet disorder in the past 12 months
• Currently receiving anticoagulation treatment
• Incomplete healing from wounds from prior surgery
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening
• Presence of positive test results for Hepatitis B or Hepatitis C
• Known history of human immunodeficiency virus (HIV) seropositive status

Contact:

• Rainier Therapeutics
• 925-413-6140

Locations:

• Research Site
• Gilbert Arizona 85234 United States

• Research Site
• Goodyear Arizona 85338 United States

• Research Site
• Duarte California 91010 United States

• Research Site
• San Francisco California 94115 United States

• Research Site
• Miami Florida 33140 United States

• Reaserach Site
• Fort Wayne Indiana 46845 United States

• Research Site
• Louisville Kentucky 40202 United States

• Research Site
• Boston Massachusetts 02215 United States

• Research Site
• Detroit Michigan 48201 United States

• Research Site
• Rochester Minnesota 55905 United States

• Research Site
• Syracuse New York 13210 United States

• Research Site
• Canton Ohio 44718 United States

• Research Site
• Dallas Texas 75390-9110 United States

• Research Site
• Olomouc 77900 Czechia

• Research Site
• Prague 12808 Czechia

• Research Site
• Ancona 60126 Italy

• Research Site
• Catania 95123 Italy

• Research Site
• Milan 20132 Italy

• Research Site
• Milan 20133 Italy

• Research Site
• Milan 20141 Italy

• Research Site
• Modena 41124 Italy

• Research Site
• Napoli 80131 Italy

• Research Site
• Negrar 37024 Italy

• Research Site
• Siena 53100 Italy

• Research Site
• Gwangju 61469 Korea, Republic of

• Research Site
• Incheon 405-760 Korea, Republic of

• Research Site
• Seongnam-si 13620 Korea, Republic of

• Research Site
• Seoul 02841 Korea, Republic of

• Research Site
• Seoul 03080 Korea, Republic of

• Research Site
• Seoul 03722 Korea, Republic of

• Research Site
• Seoul 05505 Korea, Republic of

• Research Site
• Seoul 06351 Korea, Republic of

• Research Site
• Badalona 08916 Spain

• Research Site
• Barcelona 08003 Spain

• Research Site
• Barcelona 08026 Spain

• Research Site
• Barcelona 08036 Spain

• Research Site
• Barcelona 08908 Spain

• Research Site
• Granada 18014 Spain

• Research Site
• Lugo 27003 Spain

• Research Site
• Madrid 28007 Spain

• Research Site
• Madrid 28033 Spain

• Research Site
• Madrid 28041 Spain

• Research Site
• Madrid 28046 Spain

• Research Site
• Madrid 28050 Spain

• Research Site
• Oviedo 33011 Spain

• Research Site
• Pamplona 31008 Spain

• Research Site
• Valencia 46009 Spain

• Research Site
• Vigo 36204 Spain

• Research Site
• Uppsala 751 85 Sweden

• Research Site
• Kaohsiung 81362 Taiwan

• Research Site
• Kaohsiung 83301 Taiwan

• Research Site
• Taichung 40447 Taiwan

• Research Site
• Taichung 435 Taiwan

• Research Site
• Tainan 704 Taiwan

• Research Site
• Taipei 110 Taiwan

• Research Site
• Taipei 11217 Taiwan

• Research Site
• Taoyuan 333 Taiwan

• Research Site
• Adana 01330 Turkey

• Research Site
• Ankara 06590 Turkey

• Research Site
• Antalya 07059 Turkey

• Research Site
• Bursa 16059 Turkey

• Research Site
• Edirne 22030 Turkey

• Research Site
• İstanbul 34732 Turkey

• Research Site
• İzmir 35340 Turkey

• Research Site
• Malatya 44280 Turkey

• Research Site
• London SW36JJ United Kingdom

• Research Site
• Preston PR29HT United Kingdom

View trial on ClinicalTrials.gov