SWOG clinical trial number
S0355
A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Closed
Phase
Accrual
100%
Published
Abbreviated Title
Phase I Pharmacokinetic Study
Status Notes
S0355 was permanently closed to accrual on 8/15/2006. All patient follow-up for S0355 concluded on 12/17/2007, and S0355 was added to the SWOG no-follow list at that time.
Please retain records until at least April 30, 2022. If your site has not already done so, all CTEP-supplied Epothilone B Analog (BMS-247550) must be immediately returned to the NCI Clinical Repository at 627 Lofstrand Lane, Rockville, MD 20850 ATTN: RETURNS. FDA regulations require all remaining supplies of this agent to be returned to the IND sponsor.
Please retain records until at least April 30, 2022. If your site has not already done so, all CTEP-supplied Epothilone B Analog (BMS-247550) must be immediately returned to the NCI Clinical Repository at 627 Lofstrand Lane, Rockville, MD 20850 ATTN: RETURNS. FDA regulations require all remaining supplies of this agent to be returned to the IND sponsor.
Activated
11/01/2003
Closed
08/15/2006
Participants
Limited: Institutions Listed on the Title Page
Research committees
Early Therapeutics & Rare Cancers
Treatment
BMS-247550
Eligibility Criteria Expand/Collapse
Pts must have histologically or cytologically confirmed solid tumor or lymphoma; Pts must have thoracic and upper ab. CT within 28 days prior to reg; Pts with unstable or untreated brain mets are not eligible; PS of 0-2 by Zubrod standards; Age 18 or older; ANS >= 1.5; Platelets >= 100; Creatinine <= 1.5 mg/dL within 14 days prior to reg; Liver function tests to determine stratum must be completed within 24 hrs prior to reg.; Pts with abnormal liver function are eligible; Pts with biliary obstruction for which shunt has been placed are eligible; Pts must not be pregnant or nursing; Pts with uncontrolled intercurrent illness are not eligible; Pts must not be planning to receive concurrent radiation, hormone, immune or other chemotherapy; Pts known to be HIV pos. are not eligible; Pts must agree to undergo pharmacokinetic sampling and sample submission (see Sect 15); Pts must not be taking medications that are known to be CYP3A4 inhibitors.
Publication Information Expand/Collapse
2006
A phase I pharmacokinetic (PK) study of the epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. a SWOG early therapeutics committee and NCI organ dysfunction working group trial
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