A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 180
- 试验地点
- 18
- 主要终点
- Progression Free Survival (PFS) Time
研究概览
简要总结
The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
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 —（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 (Gleason score)
- •Bisphosphonate treatment
- •Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
- •Other protocol defined inclusion criteria could apply
排除标准
- •Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC
- •Chronic and ongoing treatment with opioids
- •Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening
- •Visceral metastasis, brain metastasis
- •Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Placebo + Standard of care (SoC)
干预措施: Placebo (Other)
Placebo + Standard of care (SoC)
干预措施: Standard of Care (SoC) (Other)
EMD 525797 750 mg + SoC
干预措施: EMD 525797 (Drug)
EMD 525797 750 mg + SoC
干预措施: Standard of Care (SoC) (Other)
EMD 525797 1500 mg + SoC
干预措施: EMD 525797 (Drug)
EMD 525797 1500 mg + SoC
干预措施: Standard of Care (SoC) (Other)
结局指标
主要结局
Progression Free Survival (PFS) Time
时间窗: Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
次要结局
- Overall Survival(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Bone and Soft Tissue Lesions Composite Tumor Response(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Number of Subjects With Presence of DC in Bone Lesions(At Weeks 13, 19 and 25)
- Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion(Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI)
- Time to Tumor Progression(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Number of Subjects With New Bone Lesions Compared to Baseline(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Number of Subjects With Presence of Skeletal Related Events(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)(Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose)
- Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation(From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years)
- Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response(Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years)
- Minimum Percentage Change From Baseline in PSA Serum Concentration(Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years)
- Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)(Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI)