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| ID | Type | Description | Link |
|---|---|---|---|
| STI571BUS286T |
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Lack of feasibility secondary to slow accrual
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Patients with blood level less than 1100 will continue imatinib 400 mg daily |
|
| Arm B | Active Comparator | Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL |
|
| Arm C | Active Comparator | Patients with blood level ≥1100 will continue imatinib 400 mg daily |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesylate | Drug | 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Lesions for Progression or Response Via RECIST Criteria | Every 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne George, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Outpatient Cancer Center | Los Angeles | California | 90048 | United States | ||
| Sarcoma Oncology Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21140148 | Derived | 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. | |
| 20489620 | Derived | 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. |
| Label | URL |
|---|---|
| SARC Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 mg for Patients With Imatinib Blood Levels < 1100 | 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 |
| FG001 | 600 or 800 mg for Patients With Imatinib Blood Levels < 1100 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Imatinib mesylate | Drug | 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops |
|
|
| Imatinib mesylate | Drug | 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops |
|
|
| Santa Monica |
| California |
| 90403 |
| United States |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Northwestern University | Chicago | Illinois | 60622 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52246 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Carolinas Hematology Oncology Associates | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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 |
| FG002 | 400 mg for Patients With Imatinib Blood Levels ≥ 1100 | 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 |
| FG003 | 400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | 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 |
| BG001 | Arm B | 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 |
| BG002 | Arm C | 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 |
| BG003 | 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 Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number | participants |
| |||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Gender | Number | participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of Lesions for Progression or Response Via RECIST Criteria | Data were not collected or analyzed due to early termination. | Posted | Every 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | 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 | 0 | 0 | 0 | 0 | ||
| EG001 | Arm B | 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 | 0 | 1 | 1 | 1 | ||
| EG002 | Arm C | 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 | 0 | 3 | 2 | 3 | ||
| EG003 | 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 Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders |
| |||
| Fatigue | General disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dysguesia | Nervous system disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Pain | General disorders |
| |||
| Skin Infection | Infections and infestations |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Project Manager | SARC | (734) 930-7600 | sarc@sarctrials.org |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|