A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
研究概览
简要总结
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic, progressive hormone refractory prostate cancer
- •Adequate bone marrow, liver and kidney function
排除标准
- •Previous treatment with chemotherapy
研究组 & 干预措施
A
For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance.
干预措施: CP-751,871 (Drug)
A
For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance.
干预措施: docetaxel (Drug)
A
For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance.
干预措施: prednisone (Drug)
B
干预措施: docetaxel (Drug)
B
干预措施: prednisone (Drug)
结局指标
主要结局
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
时间窗: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)
Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =\< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as \>= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.
次要结局
- Progression Free Survival (PFS)(Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose))
- Human Anti-human Antibody (HAHA) at the Last Follow-up Visit(The last follow-up visit (150 days post last dose))
- Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs(Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose))
- Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)(Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose))
- Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871(Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose))
- Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)(Baseline (Day 1 of Cycle 1))
- Population PK Parameters of CP-751,871(Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose))
- Total Number of Circulation Tumor Cells (CTCs)(Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose))
- Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)(Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose))
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871(Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose))
- Maximum Observed Plasma Concentration (Cmax) for CP-751,871(Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose))
- Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871(Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose))