Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 101
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
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
- •Patients who have a life expectancy of at least 12 weeks
- •Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
- •Patients who have an ECOG PS of 0, or 1
- •Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
排除标准
- •Primary ocular or mucosal melanoma
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 3 years prior to study entry
- •History of cardiac disease
- •Known history of human immunodeficiency virus (HIV) infection
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006) + Dacarbazine
Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Sorafenib (Nexavar, BAY43-9006) + Dacarbazine
Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
干预措施: Dacarbazine (Drug)
Placebo + Dacarbazine
Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
干预措施: Placebo (Drug)
Placebo + Dacarbazine
Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)
PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors \[RECIST\] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.
次要结局
- Overall Survival (OS)(Time from randomization to death (the maximum treatment duration of 71.1 weeks))
- Number of Participants in Tumor Response Categories(Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days)
- Time to Progression (TTP)(Time from randomization to documented tumor progression (median time of 148 days))
- Duration of Response (DOR)(Time from initial response to documented tumor progression or death (median time of 188 days))
- Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted(Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days)
- Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted(Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days)
- Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment(Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days)
- Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted(Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days)
- Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment(Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days)