Clinical trial to investigate the safety and effect of a drug called B-701 given with another drug Docetaxel on certain types of bladder cancer that do not respond to treatment with standard therapy.
- Conditions
- Treatment of progressed or refractory metastatic UCCMedDRA version: 20.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001319-36-ES
- Lead Sponsor
- BioClin Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 261
Disease Specific Inclusion Criteria:
1.Stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or transitional cell carcinoma (TCC) arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
2.Histological or cytological diagnosis of UCC. Mixed histologies are permitted as long as TCC is the major component (i.e., > 50% of the pathologic specimen). Pure or predominant squamous cell carcinomas or adenocarcinomas are not permitted
3.Relapsed after or are refractory to at least one prior line of chemotherapy which have not included a taxane (with the exception of Cohort 3 of the Lead-In Phase which will allow the enrollment of subjects 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. If a platinum agent is contraindicated for a subject (e.g., due to pre-existing renal impairment such as creatinine clearance < 60 mL/min, myelosuppression, hearing impairment, or history of allergic reaction to platinum-containing compounds), the prior regimen(s) need not have included a platinum agent. Reason for platinum contraindication will be collected in the eCRFs
5.Prior neoadjuvant or adjuvant chemotherapy (without a taxane, except Cohort 3 of the Lead-In Phase 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. However, if the patient progressed within 12 months of the last dose of prior neoadjuvant or adjuvant chemotherapy, then this regimen of neoadjuvant or adjuvant chemotherapy will be counted as first-line chemotherapy
6.Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1; see Appendix 3). If possible, sites of measurable disease should not be within a previously irradiated site. 7.Subjects must be anticipated to have a PFS of at least 4 weeks from the time of randomization
Cohort 2, Cohort 3, and the Randomized Phase Specific Inclusion Criteria:
1.Tumor shown to have at least one of the following FGFR3 mutations: R248C, S249C, G370/2C, S371/3C, Y373/5C, G380/82R, F384/6L, K650/2X (X=E,T or M) or FGFR3-TACC3 fusion, as shown by tests performed by a CAP or CLIA certified laboratory (or equivalent outside of the US) such as Foundation Medicine, Ashion Analytics, or Paradigm Diagnostics on samples that were obtained at or after the time when the subject was found to have muscle invasive disease or high grade papillary non-muscle invasive disease. In the absence of a pre-existing genetic test results, subjects can submit archival tissue (obtained at or after the time subject was found to have muscle invasive disease) for genetic testing. When such archival tissue is not inmmediatly available, a blood sample may be submitted for initial determination of FGFR3 mutation and/or fusion status. In all cases, subsequent to subject enrolment, previous test results that were not provided by Foundation Medicine will be verified using archival tissue (if not available for the Randomized Phase, a core biopsy may be obtained). When possible, bl
1.Prior use of any other investigational drug (i.e., monoclonal antibody or experimental therapy) within 2 weeks before Cycle 1, Day 1
2.Palliative radiotherapy within 2 weeks prior to Cycle 1, Day 1
3.Prior anti-cancer therapy (e.g. biologic or other targeted therapy, chemotherapy or hormonal therapy) within 2 weeks prior to Cycle 1, Day 1
a.A washout of less than 14 days may be allowed after discussion with the Medical Monitor, provided that the subject has recovered from any clinically relevant toxicity (Exception: participants with neuropathy of Grade 1 will be allowed study entry)
b.Clinical AEs, except for alopecia, from any previous treatments must have resolved to = Grade 1
c.Laboratory AEs from any previous treatments must have resolved to = Grade 1 or to within 10% of baseline prior to Cycle 1, Day 1.
4.Prior treatment with an inhibitor that is targeted primarily to FGFRs
5.History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
6.Inability to be pre-medicated with a corticosteroid when treated with docetaxel
7.Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association (NYHA) Class III or IV cardiac disease (see Appendix 2), myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
8.History of major bleeding (requiring a blood transfusion = 2 units) not related to a tumor within the past 12 months
9.History of clinically significant coagulation or platelet disorder in the past 12 months
10.Currently receiving anticoagulation treatment
11.Incomplete healing from wounds from prior surgery; wound is larger than 2 cm in length 28 days prior to randomization
12.Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at screening. Any major episode of infection requiring treatment with IV antibiotics or hospitalization must be resolved (including the completion of the course of antibiotics) prior to Cycle 1, Day 1
13.History of other malignancy which could affect compliance with the protocol or interpretation of results
14. Subjects with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed
15. Subjects with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for = 2 years prior to Cycle 1, Day 1
16. Subjects with localized prostate cancer that has been treated with curative intent will be allowed
17.Presence of positive test results for Hepatitis B (Hepatitis B surface antigen [HBsAg] and/or total Hepatitis B core antibody [anti-HB-c]) or Hepatitis C (Hepatitis C virus [HCV] antibody serology testing)
18.Subjects positive for anti HB-c are eligible only if polymerase chain reaction (PCR) is negative for Hepatitis B viral (HBV)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method