A study of IMC-3G3 in patients with inoperable or outspread Tumors of the Gastrointestinal Stroma, already having been treated with standard treatments.

• Conditions: Gastrointestinal Stromal Tumors (GIST); MedDRA version: 14.1Level: PTClassification code 10051066Term: Gastrointestinal stromal tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022560-12-NL
• Lead Sponsor: ImClone LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-16
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

? Patient has histologically or cytologically confirmed, unresectable and/or metastatic GIST.
? Patient has measurable disease.
? Patient has documented 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 at least 12 weeks after the last dose of IMC 3G3.
? Patient has a life expectancy of = 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

? 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 has received any investigational therapy within 14 days prior to registration.
? 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified