drugset / Trial / NCT01031628
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
Phase 3
Terminated
5 enrolled
Sarcoma Alliance for Research through Collaboration
Novartis Pharmaceuticals · collab
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2011-06
- Completion
- 2011-06
Outcome
Outcome not reported
Stopped (Enrollment): “Lack of feasibility secondary to slow accrual”
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imatinib | Small molecule | 400 mg | — |
| Comparator | Imatinib | Small molecule | 600 mg | — |
| Comparator | Imatinib | Small molecule | 800 mg | — |