A Phase I Study of Ixabepilone Administered as a Daily Oral Dose on 5 Successive Days Every 21 Days in Subjects With Advanced Cancer

NCT00422097 Phase 1 COMPLETED Results posted

This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of oral ixabepilone.

Details

Lead sponsor	R-Pharm
Phase	Phase 1
Status	COMPLETED
Enrolment	40
Start date	2007-01
Completion	2011-04

Conditions

• Cancer

Interventions

• Ixabepilone, 5 mg/d
• Ixabepilone, 10 mg/d
• Ixabepilone, 15 mg/d
• Ixabepilone, 20 mg/d
• Ixabepilone, 25 mg/d
• Ixabepilone, 30 mg/d
• Ixabepilone, 25 mg, with famotidine
• Ixabepilone, 25 mg, with food

Primary outcomes

• Maximum Tolerated Dose (MTD) of Ixabepilone — Days 1 through 21 (Cycle 1)
  MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.
• Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade — Days 1 through 21 (Cycle 1), continuously
  Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.

Countries

United States