A Phase 2 Study of a Human Anti-PDGFRa Monoclonal Antibody (IMC-3G3) in Previously Treated Patients with Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)

IMCLONE LLC0 个研究点目标入组 72 人开始时间: 2012年3月1日最近更新: 2021年12月21日

适应症

试验速览

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•Patient has histologically or cytologically confirmed, unresectable and/or metastatic GIST. ? Patient has measurable disease. ? Patient has objective progression following, or intolerance to, treatment with both imatinib and sunitinib. ? Patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2. ? Patient has either: 1. prior results from KIT and PDGFRa 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 2. if prior results from KIT and PDGFRa 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. ? Patient 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 the duration of study participation. ? Patient has a life expectancy of = 3 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•Patient has untreated central nervous system metastases, and as a result, is clinically unstable with regard to neurologic function. ? Patient has a history of another primary cancer. ? Patient is currently enrolled in a clinical trial involving an investigational product. ? Patient is receiving concurrent treatment with other anticancer therapy. ? Patient has known immunodeficiency virus (HIV) infection. ? Patient has undergone major surgery within 28 days prior to registration. ? If female, patient is pregnant or breastfeeding.

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