A Phase 2, Randomized, Double Blind Study To Evaluate The Efficacy, Safety, Pharmacodynamics And Pharmacokinetics Of The Anti-alk-1 Monoclonal Antibody Pf-03446962 In Combination With Best Supportive Care Vs. Placebo Plus Best Supportive Care In Adult Patients With Advanced Hepatocellular Carcinoma Following Failure Of Sorafenib
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary purpose of the study is to explore whether treatment with PF-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer. In addition, the study will explore if adding PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are patients' characteristics (biomarkers) that may predict response to PF-03446962, and if PF-03446962 has any effect on the patients' quality of life.
详细描述
This study was terminated on June 24th, 2014 due to change in strategy of PF-03446962 clinical development. There were no safety or efficacy concerns regarding the study behind the decision to terminate the trial. The study was on temporary halt since March 10th and there are currently no patients on treatment or in the process of being randomized
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of locally advanced or metastatic liver cancer obtained by histology/cytology or by imaging
- •Documented progression on or after treatment with sorafenib, confirmed by the Investigator upon review of appropriate imaging documentation
- •Child Pugh Class A disease
- •ECOG [Eastern Cooperative Oncology Group] Performance Status (PS) 0 or 1
- •Mandatory tumor biopsy at study entry (pre-randomization, unless already collected after sorafenib progression but within 3 months of enrollment and no systemic anticancer therapies received)
排除标准
- •Prior systemic treatment for advanced liver cancer other than sorafenib-including therapy
- •Prior local therapy within 2 weeks of starting the study treatment
- •Presence of main portal vein invasion by liver cancer
研究组 & 干预措施
PF 03446962 plus best supportive care (BSC)
干预措施: PF-03446962 (Drug)
PF 03446962 plus best supportive care (BSC)
干预措施: Best Supportive Care (Other)
Placebo plus best supportive care (BSC)
Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
干预措施: Placebo (Other)
Placebo plus best supportive care (BSC)
Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Overall Survival (OS)
时间窗: From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization
OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.
次要结局
- Number of Participants With Human Anti-Human Antibodies (HAHA)(Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose))
- Time to Tumor Progression (TTP)(Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.)
- Progression-Free Survival (PFS)(Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.)
- Objective Response Rate (ORR) - Percentage of Participants With Objective Response(Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.)
- Duration of Response (DR)(From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization)
- Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks(From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization)
- Change From Baseline in Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)(Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization.)
- Maximum Serum Concentration (Cmax)(1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8)
- Trough Serum Concentration of PF-03446962 (Ctrough)(0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8)
- Presence of Sensitivity Signature(Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.)
- Ratio to Baseline of Serum Circulating Protein Concentration(Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.)
- Observed Serum Concentration of Circulating Protein(Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.)