Phase 1 Trial of Oral Ixabepilone

Status:	Terminated
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	May 2008
End Date:	June 2009

A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer

This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21
days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and
safety of this dosing schedule in participants 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

We found this trial at

sites

Georgetown University Medical Center

3800 Reservoir Rd NW
Washington, District of Columbia 20007

(202) 687-7695