A Study of IMC-3G3 in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor (GIST) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316263
• Other study ID #: 14244
• Secondary ID: CP15-1008I5B-IE-
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2011
• Last updated: February 25, 2013
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: ImClone LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Paul-Ehrlich-InstitutNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United States: Food and Drug AdministrationPoland: The Central Register of Clinical TrialsSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the tumor response of stable disease (SD) partial response, or complete response (according to RECIST 1.1 criteria) at 12 weeks in patients with Gastrointestinal Stromal Tumors (GIST) harboring PDGFRα mutations and patients with GIST not harboring PDGFRα mutations.

Description:

This trial is currently seeking participants with PDGFRα-mutations only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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, or is currently enrolled in any other type of medical research

• 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors

Intervention

Biological:
• IMC-3G3
20 mg/kg intravenously (i.v.) every 14 days

Locations

Country	Name	City	State
Belgium	ImClone Investigational Site	Edegem
Belgium	ImClone Investigational Site	Leuven
Germany	ImClone Investigational Site	Bad Saarow
Germany	ImClone Investigational Site	Berlin
Germany	ImClone Investigational Site	Essen
Germany	ImClone Investigational Site	Mannheim
Germany	ImClone Investigational Site	Tuebingen
Netherlands	ImClone Investigational Site	Leiden
Poland	ImClone Investigational Site	Warsaw
Spain	ImClone Investigational Site	Madrid
Spain	ImClone Investigational Site	Madrid
United States	ImClone Investigational Site	Boston	Massachusetts
United States	ImClone Investigational Site	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
ImClone LLC

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response of Stable Disease (SD), Partial Response, or Complete Response at 12 weeks		12 weeks	No
Secondary	Progression-Free Survival (PFS)		From enrollment to the first date of objectively determined progressive disease or death from any cause (tumor assessments performed every 6 weeks )	No
Secondary	Radiographic Objective Response Rate (ORR)		Approximately 15 Months	No
Secondary	Overall Survival (OS)		Date of first dose of study therapy to the date of death from any cause	No
Secondary	Summary listing of participants with Adverse Events		Approximately 15 Months	Yes
Secondary	Maximum Concentration (Cmax)		Day 1 of Cycle 1, 3, 6, 12 and 18	No
Secondary	Area Under the Curve (AUC)		Day 1 of Cycle 1, 3, 6, 12 and 18	No
Secondary	Half Life (t 1/2)		Day 1 of Cycle 1, 3, 6, 12 and 18	No
Secondary	Clearance (Cl)		Day 1 of Cycle 1, 3, 6, 12 and 18	No
Secondary	Volume of distribution at steady state (Vss)		Day 1 of Cycle 1, 3, 6, 12 and 18	No
Secondary	Anti-IMC-3G3 Antibody assessment		Prior to infusion on Day 1 of Cycle 1, 3, 6, 12 and 18	No
Secondary	Disease Control Rate (DCR)	determined by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)	Approximately 15 Months	No