Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

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

Imatinib mesylate

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

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

Suzanne George, MD

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

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

Novartis Pharmaceuticals

Sarcoma Alliance for Research through Collaboration

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

Arm A

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

Arm B

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

Arm C

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

Arm D

Total

<=18 years

Between 18 and 65 years

>=65 years

Age Categorical

Age Continuous

Female

Male

Gender

United States

Region of Enrollment

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.

Research Project Manager

Data were not collected or analyzed due to early termination.

Evaluation of Lesions for Progression or Response Via RECIST Criteria

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

400 mg for Patients With Imatinib Blood Levels < 1100

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

600 or 800 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients	NCT01031628	Gastrointestina...	Imatinib mesyla... Imatinib mesyla... Imatinib mesyla...	18 Years -	Sarcoma Alliance for Research through Collaboration
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients	NCT01031628	Gastrointestina...	Imatinib mesyla... Imatinib mesyla... Imatinib mesyla...	18 Years -	Sarcoma Alliance for Research through Collaboration

Spots Global Cancer Trial Database for imatinib blood levels