A Phase II Clinical Trial of BMS-247550 (NSC 710428), an Epothilone B Analog, in Renal Cell Carcinoma
BMS-247550 (NSC 710428), (ixabepilone) is a semi-synthetic analog of the natural product
The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from
the fermentation of the cellulose degrading myxobacteria, Sorangium cellulosum.
BMS-247550 is active against cancer models that are naturally insensitive to paclitaxel or
have developed resistance to paclitaxel, both in-vitro and in-vivo.
Establish the efficacy of the investigational agent BMS-247550 in patients with renal cell
carcinoma when administered as a one hour infusion on day 1 to 5 every 21 days.
Evaluate the plasma pharmacokinetics of BMS-247550.
Explore the pharmacodynamics of BMS-247550 using an assay that measures the amount of
endogenous tubulin in peripheral blood mononuclear cells (PBMC) that exists in the
polymerized versus the unpolymerized state.
Determine the extent to which pharmacodynamic changes are observed over a range of doses of
Determine if cross-resistance to BMS-247550 exists in patients who have previously received
sorafenib or sunitinib.
Age greater than 18.
Pathological confirmation of renal cell carcinoma.
Prior chemotherapy including sorafenib and sunitinib is allowed.
Phase II study.
BMS-247550 will be administered on days 1 through 5, every 21 days.
Restaging will be done every two cycles.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Tito Fojo, M.D.
National Cancer Institute, National Institutes of Health
United States: Federal Government
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