A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the tumor response of stable disease (SD), partial response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα) mutations and patients with GIST not harboring PDGFRα mutations.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has histologically or cytologically confirmed, unresectable and/or metastatic GIST
- •Participant has measurable disease
- •Participant has documented objective progression following, or intolerance to, treatment with both imatinib and sunitinib
- •Participant's Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2
- •Participant has either:
- •prior results from growth factor receptor associated with tyrosine kinase activity (KIT) and PDGFRα mutation analysis that meet analytical criteria as defined for the on-study analysis of these mutations and tumor tissue (from either primary or metastatic tumor) that can be submitted for analysis within 30 days after the first dose of study therapy; or
- •if prior results from KIT and PDGFRα mutation analysis are not available or do not meet analytical criteria as above, then tumor tissue (from either primary or metastatic tumor) must be submitted for genotype testing at the latest 28 days prior to the first dose of study therapy
- •Participant has adequate hematologic, hepatic, renal and coagulation function
- •Women of childbearing potential and sexually active males must agree to use adequate contraception prior to study and for at least 12 weeks after the last dose of IMC-3G3
- •Participant has a life expectancy of ≥ 3 months
排除标准
- •Participant has untreated central nervous system metastases, and as a result, is clinically unstable with regard to neurologic function
- •Participant has a history of another primary cancer
- •Participant has received any investigational therapy within 14 days prior to registration, or is currently enrolled in any other type of medical research
- •Participant is receiving concurrent treatment with other anticancer therapy
- •Participant has known human immunodeficiency virus (HIV) infection
- •Participant has undergone major surgery within 28 days prior to registration
- •If female, participant is pregnant or breastfeeding
结局指标
主要结局
Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks
时间窗: 12 weeks
Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) \*100.
次要结局
- Progression-Free Survival (PFS)(Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks)
- Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results(Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles))
- Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)](Baseline up to 35.9 weeks)
- Area Under the Curve (AUC)(Day 1 of Cycles 1 and 3 (14-day cycles))
- Clearance (CL)(Day 1 of Cycles 1 and 3 (14-day cycles))
- Volume of Distribution at Steady State (Vss)(Day 1 of Cycles 1 and 3 (14-day cycles))
- Overall Survival (OS)(Date of first dose of study drug to the date of death from any cause up to 57.3 weeks)
- Maximum Concentration (Cmax)(Day 1 of Cycles 1 and 3 (14-day cycles))
- Half Life (t½)(Day 1 of Cycles 1 and 3 (14-day cycles))
- Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)](Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up)
- Number of Participants With Adverse Events (AE) and Participants Who Died(Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up)