Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

This study has been terminated.
(Lack of feasibility secondary to slow accrual)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:
NCT01031628
First received: December 11, 2009
Last updated: August 22, 2013
Last verified: August 2013

December 11, 2009
August 22, 2013
January 2010
June 2011   (final data collection date for primary outcome measure)
Evaluation of Lesions for Progression or Response Via RECIST Criteria [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01031628 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
A Randomized, Phase 3 Study of Dose Escalation Versus No Dose Escalation of Imatinib In Metastatic GIST Patients With Imatinib Trough Levels Less Than 1100 Nanograms/mL

The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
  • Drug: Imatinib mesylate
    400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
    Other Names:
    • Gleevec
    • Glivec
  • Drug: Imatinib mesylate
    600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
    Other Names:
    • Gleevec
    • Glivec
  • Drug: Imatinib mesylate
    400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
    Other Names:
    • Gleevec
    • Glivec
  • Active Comparator: Arm A
    Patients with blood level less than 1100 will continue imatinib 400 mg daily
    Intervention: Drug: Imatinib mesylate
  • Active Comparator: Arm B
    Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
    Intervention: Drug: Imatinib mesylate
  • Active Comparator: Arm C
    Patients with blood level ≥1100 will continue imatinib 400 mg daily
    Intervention: Drug: Imatinib mesylate
  • Active Comparator: Arm D
    Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
    Intervention: Drug: Imatinib mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years
  • Unresectable and/or metastatic GIST
  • Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
  • For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
  • Good physical functioning (ECOG Performance Status of 0 or 1)
  • Generally, good function of organ such as liver and kidneys

Exclusion Criteria:

  • Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
  • Known intolerance of imatinib at a dose of 400 mg/day or higher
  • Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
  • Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
  • Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01031628
SARC019, STI571BUS286T
Yes
Sarcoma Alliance for Research through Collaboration
Sarcoma Alliance for Research through Collaboration
Novartis Pharmaceuticals
Principal Investigator: Suzanne George, MD Dana-Farber Cancer Institute
Sarcoma Alliance for Research through Collaboration
August 2013

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