EUCTR2017-001319-36-CZ进行中（未招募）1 期
A Phase 1b/2, Randomized, Double-Blind, Placebo Controlled, Multicenter, Parallel-Group Study of B-701 Plus Docetaxel Versus Placebo Plus Docetaxel in the Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma in Subjects who have Relapsed After, or are Refractory to Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 261
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. However, if all sites of measurable disease have been irradiated, at least one site must have demonstrated growth after irradiation
- •7.Subjects must be anticipated to have a PFS of at least 4 weeks from the time of randomization (i.e., tumor progression per RECIST v1.1 is not anticipated within the first 4 weeks after 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 immediately available, a blood sample may be submitted for initial determination of FGFR3 mutation and/or fusion status. In all cases, subsequent to subject enrollment, previous test results that were not provided by Foundation Medicine will be verifie
排除标准
- •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) deoxyribonucleic acid (DNA)
- •19.Known history of human immunodeficiency virus (HIV) seropositive status
- •20.Primary central nervous system (CNS) malignancy, or CNS metastases
- •21.Pregnancy (positive pregnancy test), lactation or breastfeeding
- •22.Weight >110 kg
- •23.Inability to
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