Phase 1 Trial of Oral Ixabepilone

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Ixabepilone (oral formulation)

Intervention Type DRUG

Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity

Interventions

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Ixabepilone (oral formulation)

Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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IXEMPRA BMS-247550

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No