Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
|Breast Cancer Lung Cancer Colon Cancer Pancreatic Cancer Head and Neck Cancer Kidney Cancer Sarcoma Hepatocellular Cancer||Drug: Pazopanib Drug: Ixabepilone||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors|
- The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination [ Time Frame: At first cycle (Week 3) ]The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.
- To Obtain Preliminary Toxicity and Tolerability of This Drug Regimen. [ Time Frame: Up to 30 days post treatment ]
|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)
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|