NCT00385580已完成2 期
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
Bristol-Myers Squibb8 个研究点 分布在 2 个国家目标入组 94 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 8
- 主要终点
- Number of Participants With a Response
研究概览
简要总结
The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •males, 18 or older
- •proven advanced prostate cancer
- •documented metastatic disease
- •rising PSA levels
- •castrate levels of testosterone
排除标准
- •symptomatic CNS (brain or spinal cord) metastasis
- •medical condition which may increase the risk of toxicity
- •any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents
- •unable to take oral medication
研究组 & 干预措施
1
Experimental
干预措施: dasatinib (Drug)
2
Experimental
干预措施: dasatinib (Drug)
结局指标
主要结局
Number of Participants With a Response
时间窗: Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.
Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =\>30% in sum of longest diameter \[LD\] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease \[PD: =\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors \[RECIST\].
Percentage of Participants With a Response
时间窗: Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.
Response = confirmed PSA response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=\>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD \[=\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on RECIST.
次要结局
- Number of Participants With a Decrease in PSA by at Least 50% From Baseline(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Months of Decrease in PSA by at Least 50% From Baseline(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With Decrease in PSA Velocity(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With Decrease in PSA Log Slope(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With Increase in PSA Doubling Time(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With CR or PR(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Number of Participants With CR, PR or SD(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Number of Participants With a Confirmed Improved Bone Scan(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Percentage of Participants With Confirmed Improved Bone Scan(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Number of Participants With Disease Progression(Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.)
- Median Number of Months to Disease Progression(Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.)
- Median Change From Baseline in Individual FAPSI Scores at Week 12(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Median Change From Baseline in Individual FAPSI Scores at Week 24(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Median Change From Baseline in Individual FAPSI Scores at Week 36(Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.)
- Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs(From start of study drug therapy up to 30 days after the last dose.)
- Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.(From start of study drug therapy up to 30 days after the last dose.)
- Number of Participants With Grade 3-4 Hematology Abnormalities(Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.)
- Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium(Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.)
- Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous(Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.)
- Number of Participants With Abnormal Lactate Dehydrogenase (LD)(Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.)
- Number of Participants With Positive Urinalysis(Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.)
- Number of Participants With QTc Prolongation(From start of study drug therapy up to 30 days after the last dose.)
- Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With a uNTx Response(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Median Number of Months of uNTx Response(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Number of Participants With BAP Response(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Median Number of Months of BAP Response(Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.)
- Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)(At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.)
- Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)(At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.)
- Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)(At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.)
- Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)(At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.)
- Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)(At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.)
- Mean Plasma Concentration at Dose 50 mg (Week 6)(At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.)
研究者
研究点 (8)
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