Phase 1 Trial of Oral Ixabepilone

Trial ID or NCT#

NCT00632424

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Branimir I Sikic

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov