Phase 1 Trial of Oral Ixabepilone

R-Pharm

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Ixabepilone (oral formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00632424

CA163-149

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Ixabepilone (oral formulation)