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

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Imatinib mesylate
Imatinib mesylate
Imatinib mesylate
Sponsored by
Sarcoma Alliance for Research through Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring GIST, Gastrointestinal stromal tumors, Exon 9, Gleevec, Imatinib blood levels

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Outpatient Cancer Center
  • Sarcoma Oncology Center
  • Washington Cancer Institute
  • Northwestern University
  • Indiana University Cancer Center
  • University of Iowa
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute
  • Carolinas Hematology Oncology Associates
  • Duke University Medical Center
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm Description

Patients with blood level less than 1100 will continue imatinib 400 mg daily

Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL

Patients with blood level ≥1100 will continue imatinib 400 mg daily

Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily

Outcomes

Primary Outcome Measures

Evaluation of Lesions for Progression or Response Via RECIST Criteria

Secondary Outcome Measures

Full Information

First Posted
December 11, 2009
Last Updated
August 22, 2013
Sponsor
Sarcoma Alliance for Research through Collaboration
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01031628
Brief Title
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of feasibility secondary to slow accrual
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sarcoma Alliance for Research through Collaboration
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
GIST, Gastrointestinal stromal tumors, Exon 9, Gleevec, Imatinib blood levels

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Patients with blood level less than 1100 will continue imatinib 400 mg daily
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
Patients with blood level ≥1100 will continue imatinib 400 mg daily
Arm Title
Arm D
Arm Type
Active Comparator
Arm Description
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate
Other Intervention Name(s)
Gleevec, Glivec
Intervention Description
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate
Other Intervention Name(s)
Gleevec, Glivec
Intervention Description
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate
Other Intervention Name(s)
Gleevec, Glivec
Intervention Description
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
Evaluation of Lesions for Progression or Response Via RECIST Criteria
Time Frame
Every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne George, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Outpatient Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Carolinas Hematology Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21140148
Citation
George S, Trent JC. The role of imatinib plasma level testing in gastrointestinal stromal tumor. Cancer Chemother Pharmacol. 2011 Jan;67 Suppl 1:S45-50. doi: 10.1007/s00280-010-1527-2. Epub 2010 Dec 8.
Results Reference
derived
PubMed Identifier
20489620
Citation
Marrari A, Trent JC, George S. Personalized cancer therapy for gastrointestinal stromal tumor: synergizing tumor genotyping with imatinib plasma levels. Curr Opin Oncol. 2010 Jul;22(4):336-41. doi: 10.1097/CCO.0b013e32833a6b8e.
Results Reference
derived
Links:
URL
http://www.sarctrials.org
Description
SARC Website

Learn more about this trial

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

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