A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
研究概览
简要总结
The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable
- •Hormone refractory prostate cancer defined as progressive based by documented 2 increase Prostate specific antigen (PSA) values over a previous reference value.
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Adequate hematological functions, liver and renal functions
排除标准
- •Known hypersensitivity to docetaxel or taxane therapy
- •Documented central nervous system or leptomeningeal metastasis at time of study entry
- •Had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.
- •Evidence of painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionuclides are necessary.
- •Have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.
研究组 & 干预措施
A: Docetaxel
Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy
干预措施: docetaxel (Drug)
A: Docetaxel
Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy
干预措施: Prednisone (Drug)
B: LY2181308 + Docetaxel
LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
干预措施: docetaxel (Drug)
B: LY2181308 + Docetaxel
LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
干预措施: LY2181308 sodium (Drug)
B: LY2181308 + Docetaxel
LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
干预措施: Prednisone (Drug)
结局指标
主要结局
Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
时间窗: Baseline to measured progressive disease or death due to any cause up to 44.68 months
PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.
Number of Participants With Adverse Events (Safety)
时间窗: First treatment dose up to 19 months
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.
次要结局
- Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)(Baseline, 18 months)
- Adverse Event Profile(First treatment dose up to 19 months)
- Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)(Predose up to 8 hours postdose in Cycle 1)
- Estimate Overall Survival(First treatment to death due to any cause up to 45.54 months)
- Estimate Duration of Overall Response(Time of response to time of measured progressive disease up to 41.00 months)
- Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)(Baseline to measured progressive disease up to 41.00 months)
- Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)(Baseline, 21 days)
- Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)(3 months)
- Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)(3 months)