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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT01316263
First received: March 14, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumor (GIST)
 Biological: IMC-3G3
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Tumor response of Stable Disease (SD), Partial Response, or Complete Response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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


Enrollment: 21
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDGFRα mutation negative
Participants with GIST with genotypes that do not have a PDGFRα mutation
 Biological: IMC-3G3
20 mg/kg intravenously (i.v.) every 14 days
Experimental: PDGFRα mutation positive
Participants with GIST with genotypes that have a PDGFRα mutation
 Biological: IMC-3G3
20 mg/kg intravenously (i.v.) every 14 days

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316263

Locations
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02215
Belgium
ImClone Investigational Site
Edegem, Belgium, B-2650
ImClone Investigational Site
Leuven, Belgium, B-3000
Germany
ImClone Investigational Site
Bad Saarow, Germany, 15526
ImClone Investigational Site
Berlin, Germany, 13125
ImClone Investigational Site
Essen, Germany, 45122
ImClone Investigational Site
Mannheim, Germany, 68167
ImClone Investigational Site
Tuebingen, Germany, 72076
Netherlands
ImClone Investigational Site
Leiden, Netherlands, 2300 RC
Poland
ImClone Investigational Site
Warsaw, Poland, 02-781
Spain
ImClone Investigational Site
Madrid, Spain, 28050
ImClone Investigational Site
Madrid, Spain, 28041
Sponsors and Collaborators
ImClone LLC
Investigators
Study Director: Email: ClinicalTrials@Imclone.com ImClone LLC
  More Information

No publications provided

Responsible Party: ImClone LLC
ClinicalTrials.gov Identifier: NCT01316263     History of Changes
Other Study ID Numbers: 14244, CP15-1008, I5B-IE-JGDH, 2010-022560-12
Study First Received: March 14, 2011
Last Updated: February 25, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Paul-Ehrlich-Institut
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United States: Food and Drug Administration
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013