A Phase Ib/ii, Multicenter, Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).
详细描述
On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed advanced/metastatic solid tumor
- •Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors
- •Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)
- •Adequate laboratory tests
- •Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and age > or = 18 years
排除标准
- •Patients intolerant of prior anti-angiogenic agents
- •Recent history of bleeding or bleeding disorders
- •History of tumors in the brain
- •History of heart problems
- •History of severe allergic reaction to antibody therapy
研究组 & 干预措施
Cohort 1
CVX-060 + sunitinib
干预措施: CVX-060 + sunitinib (Drug)
Cohort 2
CVX-060 + sunitinib
干预措施: CVX-060 + sunitinib (Drug)
Cohort 3
CVX-060 + sunitinib
干预措施: CVX-060 + sunitinib (Drug)
Expanded cohort
CVX-060 + sunitinib
干预措施: CVX-060 + sunitinib (Drug)
Phase II - Arm A
CVX-060 + sunitinib
干预措施: CVX-060 + sunitinib (Drug)
Phase II - Arm B
sunitinib alone
干预措施: Sunitinib (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Baseline up to Cycle 1( Day 1 to Day 42)
The MTD was defined as the dose level at which less than or equal to (\<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having \>= 2/6 participants with DLT.
Progression-free Survival (PFS)
时间窗: Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)
PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.
次要结局
- Pharmacokinetic Parameters of CVX-060(Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication))
- Number of Participants With Dose-limiting Toxicities (DLT)(Baseline up to 28 days post last dose of study medication)
- Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels(Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28))
- Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)(Baseline up to 28 days post last dose of study medication)
- Percentage of Participants With Objective Response(Baseline up to 7 days post last dose of study medication)
- Duration of Response(Baseline up to 7 days post last dose of study medication)
- Number of Participants With Anti- CVX-060 Antibodies(Baseline up to 28 days after last CVX-060 dose)