NCT00884676

Ixabepilone and Sunitinib Malate in Treating Patients With Progressive Advanced Solid Tumors

A Phase I Trial of Weekly and Every Three Weeks Ixabepilone and Sunitinib in Solid Tumor Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jaime Merchan · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when given together with sunitinib malate in treating patients with progressive advanced solid tumors.

Detailed description

OBJECTIVES: Primary * To determine the safety and toxicity profile of ixabepilone in combination with sunitinib malate in patients with progressive, advanced non-hematologic malignancies. * To determine the recommended phase II dose of ixabepilone given weekly versus once every three weeks in combination with a fixed dose of sunitinib malate in these patients. Secondary * To evaluate the pharmacokinetic profiles of the combination of ixabepilone and sunitinib malate and correlate them with activity and/or toxicity. * To obtain preliminary efficacy data (complete response, partial response, or stable disease) of these treatment combinations. * To correlate changes in angiogenesis biomarkers with clinical (safety and efficacy) and pharmacokinetic parameters in patients treated with these drug combinations. * To estimate the optimal biological dose. OUTLINE: This is a dose escalation study of ixabepilone. Patients are assigned to 1 of 2 treatment groups. * Schedule A: Patients receive ixabepilone IV on days 1, 8, and 15. Beginning on day 8 of course 1, patients also receive oral sunitinib malate once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Schedule B: Patients receive ixabepilone IV on day 1. Beginning on day 8 of course 1, patients also receive oral sunitinib malate once daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for biomarker and pharmacokinetic studies by flow cytometry. After completion of study therapy, patients are followed at 30 days and every 3 months for 1 year.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	Ixabepilone	Administered intravenously. Dosage assigned by Phase I center as determined by dose-escalation schedule: * Schedule A: Weekly for 3 weeks each cycle (Days 1, 8 and 15) * Schedule B: Day 1 of each 3-week cycle.
DRUG	Sunitinib	For both Schedules A and B, daily, orally, starting on Day 8 of Cycle 1

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-11-01
• Completion: 2015-07-01
• First posted: 2009-04-21
• Last updated: 2015-10-09

Locations

1 site across 1 country: United States