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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

March 14, 2011
February 25, 2013
August 2011
May 2012   (final data collection date for primary outcome measure)
Tumor response of Stable Disease (SD), Partial Response, or Complete Response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Tumor response of Stable Disease (SD) or better at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01316263 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
A Study of IMC-3G3 in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors
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)

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor (GIST)
Biological: IMC-3G3
20 mg/kg intravenously (i.v.) every 14 days
  • Experimental: PDGFRα mutation negative
    Participants with GIST with genotypes that do not have a PDGFRα mutation
    Intervention: Biological: IMC-3G3
  • Experimental: PDGFRα mutation positive
    Participants with GIST with genotypes that have a PDGFRα mutation
    Intervention: Biological: IMC-3G3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
November 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Germany,   Netherlands,   Poland,   Spain
 
NCT01316263
14244, CP15-1008, I5B-IE-JGDH, 2010-022560-12
No
ImClone LLC
ImClone LLC
Not Provided
Study Director: Email: ClinicalTrials@Imclone.com ImClone LLC
ImClone LLC
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP