A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 58
- 主要终点
- Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium
研究概览
简要总结
The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
- •Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
- •Calculated creatinine clearance ≤60 mL/min: OR
- •New York Heart Association Classification Stage III-IV Congestive Heart Failure
- •Measurable disease documented by imaging with at least one uni-dimensional lesion
- •Adequate performance status (ECOG 0, 1, or 2)
- •Men and women ≥18 years of age
排除标准
- •Patients in whom radiation or surgery is indicated
- •Current neuropathy ≥ CTCAE grade 3
- •Prior radiation to ≥ 30% of bone marrow
- •Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
- •Prior allergy to any vinca alkaloid
研究组 & 干预措施
vinflunine and gemcitabine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
干预措施: Vinflunine (Drug)
vinflunine and gemcitabine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
干预措施: Gemcitabine (Drug)
placebo and gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
干预措施: Gemcitabine (Drug)
placebo and gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
干预措施: Placebo (Other)
结局指标
主要结局
Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium
时间窗: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
次要结局
- Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)(Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision)
- Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade(Following Day 1 to no longer than 30 days after last dose of study medication)
- Duration of Response in Participants With Best Response of CR or PR(Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision)
- Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation(Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision)
- Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria(Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision)
- Time to Response in Participants With Best Response of CR or PR(Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision)
- Overall Survival of Participants With TCC of the Urothelium(Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision)
- Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade(Following Day 1 to no longer than 30 days after last dose of study medication)