NCT01281865

Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma

A Phase 1b/2 Study of Imatinib in Combination With Everolimus in Synovial Sarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II clinical trial is studying the side effects and best dose of everolimus when given with imatinib mesylate and to see how well they work in treating patients with locally advanced, locally recurrent or metastatic soft tissue sarcoma. Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) of everolimus in combination with imatinib mesylate in patients with synovial sarcoma. (Phase I) II. To determine the overall response rate (RR = CR + PR). (Phase II) SECONDARY OBJECTIVES: I. To determine RR, progression-free survival (PFS), and overall survival (OS). (Phase I) II. To determine predictors of response. (Phase II) III. To obtain tissue biopsy and plasma samples for correlative studies pre- and post-treatment. (Phase II) OUTLINE: This is a phase I, dose-escalation study of everolimus followed by a phase II study. Patients receive everolimus orally (PO) once daily and imatinib mesylate PO once daily on days 1-28. Course repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tumor tissue sample collection at baseline and periodically during study for correlative biomarker and protein expression studies. After completion of study therapy, patients are followed up for 30 days.

Conditions

• Adult Synovial Sarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
OTHER	diagnostic laboratory biomarker analysis	Correlative studies
DRUG	everolimus	Given PO
DRUG	imatinib mesylate	Given PO

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-01-24
• Last updated: 2014-10-08
• Results posted: 2014-10-08

Locations

1 site across 1 country: United States