A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer
18 Years
N/A
Both
Advanced Solid Tumors
Trial Information
A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer
Inclusion Criteria:
- Males and females, 18 or older
- Histologically or cytologically confirmed diagnosis of solid tumor malignancy
- Measurable or non-measurable disease as defined by Response Evaluation Criteria
In Solid Tumors (RECIST) criteria
- Karnofsky Performance Status (KPS) of 70-100
- Recovered from toxicities resulting from previous therapies
Exclusion Criteria:
- More than 3 prior cytotoxic regimens in the metastatic setting
- Current or recent gastrointestinal (GI) disease that would impact the absorption of
study drug
- Inability to swallow whole capsules
- Inadequate hepatic and renal function
- Function exposure to any epothilone
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With a Dose-Limiting Toxicity (DLT)
Outcome Description:
DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.
Outcome Time Frame:
During Cycle 1 (Day 0 through Day 21)
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA163-149
NCT ID:
NCT00632424
Start Date:
May 2008
Completion Date:
June 2009
Related Keywords:
- Advanced Solid Tumors
Name | Location |
|---|---|
| Stanford University | Stanford, California 94305 |
| Georgetown University Medical Center | Washington, District of Columbia 20007 |
