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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of lesions for progression or response via RECIST criteria

Outcome Time Frame:

Every 3 months

Safety Issue:

No

Principal Investigator

Suzanne George, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

SARC019

NCT ID:

NCT01031628

Start Date:

January 2010

Completion Date:

June 2011

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • GIST
  • Gastrointestinal stromal tumors
  • Exon 9
  • Gleevec
  • Imatinib blood levels
  • Gastrointestinal Stromal Tumors

Name

Location

University of IowaIowa City, Iowa  52242
MD Anderson Cancer CenterHouston, Texas  77030-4096
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Washington Cancer InstituteWashington, District of Columbia  20010
Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Sarcoma Oncology CenterSanta Monica, California  90403
Cedars-Sinai Outpatient Cancer CenterLos Angeles, California  
Carolinas Hematology Oncology AssociatesCharlotte, North Carolina  28203