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

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ClinicalTrials.gov Identifier: NCT01031628
Recruitment Status : Terminated (Lack of feasibility secondary to slow accrual)
First Posted : December 14, 2009
Results First Posted : August 16, 2013
Last Update Posted : September 9, 2013
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumors
Intervention Drug: Imatinib mesylate
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 400 mg for Patients With Imatinib Blood Levels < 1100 600 or 800 mg for Patients With Imatinib Blood Levels < 1100 400 mg for Patients With Imatinib Blood Levels ≥ 1100 400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors
Hide Arm/Group Description

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Period Title: Overall Study
Started 0 1 3 0
Completed 0 0 0 0
Not Completed 0 1 3 0
Reason Not Completed
Study terminated early             0             1             3             0
Arm/Group Title Arm A Arm B Arm C Arm D Total
Hide Arm/Group Description

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Total of all reporting groups
Overall Number of Baseline Participants 0 1 3 0 4
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 3 participants 0 participants 4 participants
<=18 years 0 0 0
Between 18 and 65 years 0 3 3
>=65 years 1 0 1
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 1 participants 3 participants 0 participants 4 participants
71 56.7  (8.39) 60.25  (7.68)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 3 participants 0 participants 4 participants
Female 1 1 2
Male 0 2 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 3 participants 0 participants 4 participants
1 3 4
1.Primary Outcome
Title Evaluation of Lesions for Progression or Response Via RECIST Criteria
Hide Description [Not Specified]
Time Frame Every 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected or analyzed due to early termination.
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group Description:

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B Arm C Arm D
Hide Arm/Group Description

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

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

Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

All-Cause Mortality
Arm A Arm B Arm C Arm D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B Arm C Arm D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/1 (0.00%)      0/3 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B Arm C Arm D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      1/1 (100.00%)      2/3 (66.67%)      0/0    
Gastrointestinal disorders         
Nausea  0/0  0 1/1 (100.00%)  2 1/3 (33.33%)  1 0/0  0
Diarrhea  0/0  0 0/1 (0.00%)  0 2/3 (66.67%)  2 0/0  0
General disorders         
Fatigue  0/0  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/0  0
Pain  0/0  0 0/1 (0.00%)  0 1/3 (33.33%)  2 0/0  0
Infections and infestations         
Skin Infection  0/0  0 1/1 (100.00%)  2 0/3 (0.00%)  0 0/0  0
Musculoskeletal and connective tissue disorders         
Back Pain  0/0  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/0  0
Nervous system disorders         
Dysguesia  0/0  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/0  0
Headache  0/0  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/0  0
Psychiatric disorders         
Insomnia  0/0  0 1/1 (100.00%)  1 1/3 (33.33%)  1 0/0  0
A decision was made to discontinue the SARC019 trial effective March 3, 2011, due to lack of feasibility secondary to slow accrual. Due to early termination of the study, no patients were analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Research Project Manager
Organization: SARC
Phone: (734) 930-7600
Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT01031628     History of Changes
Other Study ID Numbers: SARC019
STI571BUS286T
First Submitted: December 11, 2009
First Posted: December 14, 2009
Results First Submitted: June 12, 2013
Results First Posted: August 16, 2013
Last Update Posted: September 9, 2013