A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 14
- 主要终点
- To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm.
研究概览
简要总结
The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter, international trial enrolling patients with metastatic CRPC who had a response to first-line docetaxel therapy and have prostate cancer-related pain with progression of disease. The intended intervention is second-line treatment with docetaxel retreatment or cabazitaxel plus study agent, where custirsen is to be administered in the investigational arm and placebo is to be administered in the control arm.
Selection of the chemotherapy (docetaxel re-treatment or cabazitaxel) is to be determined by the treating physician, based on the patient's first-line response.
The study will primarily assess pain and analgesic use for evaluation of durable pain palliation in response to study treatment. Pain and analgesic use will be obtained via a 3rd party contact center (direct contact with patient).
Study treatment starts with a Loading Dose Period during which three infusions of study agent (custirsen vs. placebo) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel or cabazitaxel on a 21-day cycle with weekly study agent (custirsen vs. placebo) infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Patients will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. If study treatment is completed or discontinued prior to pain progression, 6-day assessments will continue every 3 weeks until pain progression is documented. Follow-up after study treatment will occur for safety parameters for 3 weeks after the last study agent infusion in all patients. Survival status updates are to be reported every 12 weeks following documentation of pain progression. The amount of time that patients remain on the study will vary; but the average survival of these patients who receive second line taxane treatment is expected to be 14 to 15 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Custirsen
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: custirsen sodium (Drug)
Custirsen
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: docetaxel (Drug)
Custirsen
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: cabazitaxel (Drug)
Custirsen
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: prednisone (Drug)
Placebo
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: isotonic, 0.9% sodium chloride (Drug)
Placebo
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: docetaxel (Drug)
Placebo
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: cabazitaxel (Drug)
Placebo
Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.
干预措施: prednisone (Drug)
结局指标
主要结局
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm.
时间窗: 3 to 6 months
次要结局
- To ascertain whether patients randomized to the investigational arm have a longer time to pain progression as compared to patients randomized to the control arm.(6 months.)
- Safety(6 months)