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

Phase 2TerminatedNCT01316263

Eli Lilly and Company21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Stromal Tumor (GIST)

Interventions

OlaratumabBIOLOGICAL

Administered IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

ImClone Investigational Site

Chicago, Illinois, United States

ImClone Investigational Site

Boston, Massachusetts, United States

ImClone Investigational Site

Edegem, Belgium

Outcomes

Primary Outcomes

Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 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.

Time frame: 12 weeks

Secondary Outcomes

Progression-Free Survival (PFS)

PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.

Time frame: Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks

Data from ClinicalTrials.gov

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