Study Stopped
program has been put on hold by the sponsor
Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
FIERCE-21
A Dose Escalation, Expansion Study of Vofatamab (B-701) Alone, Plus Docetaxel, or Versus Docetaxel in Subjects With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Relapsed After, or Are Refractory to Standard Therapy
2 other identifiers
interventional
71
9 countries
65
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2015
Longer than P75 for phase_1
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedResults Posted
Study results publicly available
February 17, 2020
CompletedMarch 9, 2020
February 1, 2020
4.4 years
March 16, 2015
February 3, 2020
February 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Efficacy Outcome: Progression Free Survival (PFS)
Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3-4 years
Study Arms (3)
Vofatamab plus docetaxel
ACTIVE COMPARATORIV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.
Placebo plus docetaxel
PLACEBO COMPARATORIV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor
Vofatamab
EXPERIMENTALIV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Histological or cytological diagnosis of UCC.
- 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)
- 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).
- 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.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Patient must be confirmed to have a FGFR3 genomic alteration at the time of documentation of advanced disease.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Goodyear, Arizona, 85338, United States
Research Site
Duarte, California, 91010, 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
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, South Korea
Research Site
Incheon, 405-760, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
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 City, 81362, Taiwan
Research Site
Kaohsiung City, 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 District, 333, Taiwan
Research Site
Adana, 01330, Turkey (Türkiye)
Research Site
Ankara, 06590, Turkey (Türkiye)
Research Site
Antalya, 07059, Turkey (Türkiye)
Research Site
Bursa, 16059, Turkey (Türkiye)
Research Site
Edirne, 22030, Turkey (Türkiye)
Research Site
Istanbul, 34732, Turkey (Türkiye)
Research Site
Izmir, 35340, Turkey (Türkiye)
Research Site
Malatya, 44280, Turkey (Türkiye)
Research Site
London, SW36JJ, United Kingdom
Research Site
Preston, PR29HT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Rainier Therapeutics
Study Officials
- STUDY CHAIR
Rainier Therapeutics
Rainier Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 30, 2015
Study Start
June 1, 2015
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
March 9, 2020
Results First Posted
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share