A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors
Condition: Gastrointestinal Stromal Tumor (GIST)
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: Olaratumab
Intervention description: Administered IV
Intervention MeSH terms: Olaratumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

               1. 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

               2. 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

        Exclusion Criteria:

          -  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