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

Phase 1
18 Years
Not Enrolling

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Trial Information

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

Inclusion Criteria:

- Confirmed diagnosis of solid tumor malignancy unresponsive to current treatment

- Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in
Solid Tumors

- Lapse of at least 1 week since minor surgery and of at least 3 weeks since major
surgery and radiation therapy

- Eastern Cooperative Oncology Group performance status of 0-1

- Lapse of at least 4 weeks since immunotherapy or chemotherapy

- Negative pregnancy test result within 72 hours of study drug administration for any
woman of childbearing potential (WOCBP)

Exclusion Criteria:

- WOCBP unable or unwilling to use birth control during study and for up to 4 weeks
after study completion

- Women who are pregnant or breastfeeding

- Fertile men not using effective birth control with partners who are WOCBP

- Gastrointestinal(GI) disease or GI tract surgery that could impact drug absorption

- Inability to swallow capsules

- Inability to be venipunctured or to tolerate venous access

- Known symptomatic brain metastases

- Common Terminology Criteria for Adverse Events Grade 2 or greater neuropathy or
history of Grade 3 or greater neuropathy

- Psychiatric conditions inhibiting compliance with protocol requirements

- Uncontrolled medical disorder or active infection that would impair participant's
ability to receive protocol therapy or whose control may be jeopardized by the study
treatment protocol

- Inadequate hematologic, hepatic, or renal function

- History of significant drug allergy

- Previous exposure to ixabepilone

- Exposure to any investigational drug or placebo within 4 weeks of enrollment

- Concurrent chemotherapy regimen

- Use of cytochrome P4503A4 inhibitors or inducers within 2 weeks of treatment
initiation (unless approved by medical monitor)

- Use of steroids (except as antiemetic)

- Prisoners or subjects involuntarily detained for treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Ixabepilone

Outcome Description:

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.

Outcome Time Frame:

Days 1 through 21 (Cycle 1)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

April 2011

Related Keywords:

  • Cancer



Georgetown University Medical Center Lombardi Cancer Center Washington, District of Columbia  20007
Wayne State University (Hwcrc) Detroit, Michigan  48201