Solid Tumors Using Ixabepilone and Dasatinib
Patients are being asked to take part in this study because they have been diagnosed with an advanced solid tumor that is not responding to standard treatments. This study will find the highest dose of ixabepilone and dasatinib in combination that can be given without causing severe side effects.
Both ixabepilone and dasatinib have individually been tested in many (several thousand) patients, however the combination of the two drugs has not yet been tested in humans.
All patients who will take part in this study will receive combined drug therapy of dasatinib and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that will be given by vein (IV).
All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors|
- The primary outcome is to determine the safety and toxicity of ixabepilone and dasatinib in combination in patients with metastatic or locally advanced/unresectable solid tumors that have progressed through standard therapy. [ Time Frame: From study start until completion of study followup. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks). ] [ Designated as safety issue: Yes ]While on the drug combination, patients will be seen in the clinic every 3 weeks. These visits will assess the safety and tolerablility of the drug regimen. The drug combination continues until disease progression or unacceptable toxicity. When one of those two events occurs, the patient enters the followup phase. During the followup phase, the patient will return to the clinic every 4 weeks until drug-related toxicities resolve.
- The secondary outcome is to evaluate tumor response as a preliminary assessment of clinical activity. [ Time Frame: From start of the study until completion of the drug regimen. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks). ] [ Designated as safety issue: No ]Disease status will be monitored via diagnostic imaging every other cycle (every six weeks) until the patient is finished with drug combination. The drug combination continues until disease progression or unacceptable toxicity.
|Study Start Date:||July 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily. All participants will receive the study drugs at a baseline dose. If the side effects are minimal and tolerable, the next cycle of study drugs will be given at same dosage. If side effects are intolerable, then the dose will be lowered.
by vein once every 3 weeks
Other Name: ixempraDrug: Dasatinib
by mouth once daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717704
|United States, District of Columbia|
|Washington Cancer Institute|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Sandra M Swain, MD||Washington Hospital Center|