Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
研究概览
简要总结
The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin.
Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease.
Cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •You are expected to be alive in the 12 weeks.
- •You are at least 18 years old.
- •You live close enough to the doctor's office to attend all of your required visits.
- •You have not been treated with chemotherapy for your prostate cancer (cohort 1).
- •Must have evidence of androgen-independent PSA-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (<50 ng/dL) maintained by luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have rising PSA values of <=5 ng/mL (at least 3 measurements 1 week apart) with castrate levels of testosterone <50 ng/dL following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1)
- •No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any other indication within 2 years of study entry. NOTE: Participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1)
- •You have had one prior docetaxel-based chemotherapy regimen (cohort 2).
- •You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2).
- •Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (PSA only participants are not eligible) defined as either: clinical, PSA or radiographic disease progression while receiving docetaxel-based therapy or PSA and/or radiographic progression at any time after completion of a docetaxel-containing regimen with PSA progression defined as a 25% increase in PSA from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (CT) imaging. Note: Participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2)
- •Your organs must be functioning properly.
排除标准
- •You are unable to swallow pills.
- •You have another illness besides your prostate cancer.
- •You have taken another experimental drug within the last 30 days.
- •You have a serious heart condition.
- •You are receiving another anti-cancer therapy.
研究组 & 干预措施
Enzastaurin-Cohort 1
Chemo-naive participants who had androgen-independent prostate cancer with rising prostate-specific antigen (PSA) levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
干预措施: enzastaurin (Drug)
Enzastaurin-Cohort 2
Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
干预措施: enzastaurin (Drug)
结局指标
主要结局
Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
时间窗: Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)
Objective responders were defined as participants (pts) in Cohort 1 who met prostate-specific antigen (PSA) response criteria. PSA Complete response (CR) was defined as a decrease in PSA to an undetectable level (\<0.2 ng/mL) confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease. PSA Partial Response (PR) was defined as a decrease in PSA of \>=50% at any time during the study. The decline of \>=50% in PSA must be from a baseline value of \>5 ng/mL and must be confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease.
Cohort 2 - Progression-free Survival (PFS)-Overall
时间窗: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 weeks)
PFS was defined as the time from date of enrollment to first occurrence of (1) tumor progression (defined per Response Evaluation Criteria In Solid Tumors \[RECIST\]) for soft tissue lesions, and/or appearance of \>=2 new lesions on bone scan (confirmed \>=6 weeks later); (2) skeletal event (pathological bone fracture and/or need for palliative radiotherapy); (3) symptomatic progression (worsening of Eastern Cooperative Oncology Group (ECOG) performance status (PS) and/or weight loss \>10% from baseline and/or increase in analgesic consumption and pain); or (4) Death due to any cause. PFS was censored at date of last objective progression-free observation for participants who were still alive and had not progressed. Participants who took any subsequent systemic anticancer therapy prior to progression or death were censored at date of last objective progression-free disease assessment prior to the date of the subsequent systemic anticancer therapy.
次要结局
- Cohort 1 - Number of Participants With a 3-month PSA Level Decline of Greater Than or Equal to 30%(baseline to 3 months)
- Cohort 1 - Progression-free Survival (PFS)-Overall(baseline to date of disease progression, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks))
- Cohort 2 - 3-month PSA Level Decline of Greater Than or Equal to 30%(baseline to 3 months)
- Cohort 2 - PSA Velocity(baseline, 2 months and 3 months)
- Cohort 2 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)(baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months))
- Cohort 2 - Percentage of Participants With Progression Free Survival (PFS) at 6 Months and 12 Months(6 months and 12 months)
- Cohort 1 - PSA Velocity(baseline, 2 months and 3 months)
- Cohort 1 - Duration of Response(time of response to progressive disease, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks))
- Cohort 2 - Overall Survival(baseline to date of death from any cause (up to 69.6 weeks))
- Cohort 2 - Duration of Response(time of response to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months))