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:
Sarcoma Alliance for Research through Collaboration
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: March 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumors |
Drug: Imatinib mesylate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Sarcoma Alliance for Research through Collaboration:
Primary Outcome Measures:
- Evaluation of lesions for progression or response via RECIST criteria [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm A
Patients with blood level less than 1100 will continue imatinib 400 mg daily
|
Drug: Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
|
|
Active Comparator: Arm B
Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
|
Drug: Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
|
|
Active Comparator: Arm C
Patients with blood level ≥1100 will continue imatinib 400 mg daily
|
Drug: Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
|
|
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
|
Drug: Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031628
Locations
| United States, California | |
| Cedars-Sinai Outpatient Cancer Center | |
| Los Angeles, California, United States, 90048 | |
| Sarcoma Oncology Center | |
| Santa Monica, California, United States, 90403 | |
| United States, District of Columbia | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60622 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52246 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, North Carolina | |
| Carolinas Hematology Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Suzanne George, MD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sarcoma Alliance for Research through Collaboration |
| ClinicalTrials.gov Identifier: | NCT01031628 History of Changes |
| Other Study ID Numbers: | SARC019, STI571BUS286T |
| Study First Received: | December 11, 2009 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sarcoma Alliance for Research through Collaboration:
|
GIST Gastrointestinal stromal tumors Exon 9 Gleevec Imatinib blood levels |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013