Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.
Head and Neck Cancer
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors|
- To determine the optimal tolerated regimen (OTR) of pazopanib and ixabepilone when used in combination by evaluation of toxicity and tolerability [ Time Frame: At first cycle (Week 3) ] [ Designated as safety issue: Yes ]
- To obtain preliminary toxicity and tolerability of this drug regimen. [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Pazopanib and Ixabepilone
Patient receives assigned dose level:
Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 25 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.
Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.
Other Names:Drug: Ixabepilone
Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle
Other Name: IXEMPRA(TM)
Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012362
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Arkaduisz Z Dudek, MD||Masonic Cancer Center, University of Minnesota|