Gastrointestinal Stromal TumorsPhase 3NCT01031628
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
A Phase 3 study testing Imatinib mesylate in people with Gastrointestinal Stromal Tumors, run by Sarcoma Alliance for Research through Collaboration at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Imatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60622
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52246
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Sarcoma Oncology Center
Santa Monica, California, 90403
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
About this study
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
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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Imatinib mesylate
- Keywords
- GIST, Gastrointestinal stromal tumors, Exon 9, Gleevec, Imatinib blood levels
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib mesylateDrug
Also called Gleevec, Glivec
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Imatinib mesylateDrug
Also called Gleevec, Glivec
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Imatinib mesylateDrug
Also called Gleevec, Glivec
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Patients with blood level less than 1100 will continue imatinib 400 mg daily Receives: Drug: Imatinib mesylate |
| Arm B | Active comparator | Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL Receives: Drug: Imatinib mesylate |
| Arm C | Active comparator | Patients with blood level ≥1100 will continue imatinib 400 mg daily Receives: Drug: Imatinib mesylate |
| Arm D | Active comparator | Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily Receives: Drug: Imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Lesions for Progression or Response Via RECIST Criteria
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Lack of feasibility secondary to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Suzanne George, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031628
- Sponsor's protocol ID
- SARC019
- Other IDs
- STI571BUS286T
- Status last verified
- Aug 2013
- First submitted
- 11 Dec 2009
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21140148Marrari 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.
PubMed 20489620
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01031628
- Acronym / sponsor ID
- SARC019
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- GIST, Gastrointestinal stromal tumors, Exon 9, Gleevec, Imatinib blood levels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of feasibility secondary to slow accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sarcoma Alliance for Research through CollaborationUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Posted 16 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Imatinib mesylatePatients with blood level less than 1100 will continue imatinib 400 mg daily |
| Arm B | Active comparator | Drug: Imatinib mesylatePatients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL |
| Arm C | Active comparator | Drug: Imatinib mesylatePatients with blood level ≥1100 will continue imatinib 400 mg daily |
| Arm D | Active comparator | Drug: Imatinib mesylatePatients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib mesylateAlso: Gleevec, Glivec400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | Drug | Arm A, Arm C |
| Imatinib mesylateAlso: Gleevec, Glivec600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | Drug | Arm B |
| Imatinib mesylateAlso: Gleevec, Glivec400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | Drug | Arm D |
Primary outcome
Evaluation of Lesions for Progression or Response Via RECIST Criteria
Time frame: Every 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21140148George 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.
- Derived from this study: PubMed 20489620Marrari 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.
- SARC WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne George, MD principal investigator
Dana-Farber Cancer Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib mesylate in people with Gastrointestinal Stromal Tumors, run by Sarcoma Alliance for Research through Collaboration at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Lesions for Progression or Response Via RECIST Criteria (time frame: Every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.