Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
NCT ID: NCT02401542
Last Updated: 2020-03-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
71 participants
INTERVENTIONAL
2015-06-30
2019-11-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vofatamab plus docetaxel
IV 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.
Vofatamab
Docetaxel
Placebo plus docetaxel
IV 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
Docetaxel
Placebo
Vofatamab
IV 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.
Vofatamab
Interventions
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Vofatamab
Docetaxel
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
1. Patient must be confirmed to have a FGFR3 genomic alteration at the time of documentation of advanced disease.
2. Relapsed after or are refractory to an immune checkpoint inhibitor. This inclusion criterion does not apply if the checkpoint inhibitor is contraindicated.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rainier Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Rainier Therapeutics
Role: STUDY_CHAIR
Rainier Therapeutics
Locations
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Research Site
Gilbert, Arizona, United States
Research Site
Goodyear, Arizona, United States
Research Site
Duarte, California, United States
Research Site
Miami, Florida, United States
Reaserach Site
Fort Wayne, Indiana, United States
Research Site
Louisville, Kentucky, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Syracuse, New York, United States
Research Site
Dallas, Texas, United States
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Ancona, , Italy
Research Site
Catania, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Modena, , Italy
Research Site
Napoli, , Italy
Research Site
Negrar, , Italy
Research Site
Siena, , Italy
Research Site
Gwangju, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Badalona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Granada, , Spain
Research Site
Lugo, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Oviedo, , Spain
Research Site
Pamplona, , Spain
Research Site
Valencia, , Spain
Research Site
Vigo, , Spain
Research Site
Uppsala, , Sweden
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Antalya, , Turkey (Türkiye)
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Edirne, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Malatya, , Turkey (Türkiye)
Research Site
London, , United Kingdom
Research Site
Preston, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-001319-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B-701-U21
Identifier Type: -
Identifier Source: org_study_id
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