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)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

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

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov