A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

Lilly

Status and phase: Terminated; Phase 2

Conditions: Gastrointestinal Stromal Tumor (GIST)

Treatments: Biological: Olaratumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01316263

2010-022560-12 (EudraCT Number)

CP15-1008 (Other Identifier)

14244

I5B-IE-JGDH (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

PDGFRα mutation negative

Experimental group

Description:

Participants with GIST with genotypes that do not have a PDGFRα mutation given 20 milligrams per kilogram (mg/kg) Olaratumab intravenously (IV) every 14 days.

Treatment:

Biological: Olaratumab

PDGFRα mutation positive

Experimental group

Description:

Participants with GIST with genotypes that have a PDGFRα mutation given 20 mg/kg Olaratumab IV every 14 days.

Treatment:

Biological: Olaratumab