Ixabepilone Administered as an Enteric Coated Formulation.

R-Pharm

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cancer

Treatments: Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309049

CA163-088

Details and patient eligibility

About

The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG status of 0-2.

Exclusion criteria

• Unable to swallow pills.
• Current or recent GI disease or GI surgery.
• Brain mets.
• Severe nerve damage.
• ANC <1,500/mm3
• Platelets <125K.
• Bilirubin >=1.5 times the IULN.
• ALT/AST >=1.5 times the IULN.
• Creatine >1.5 times the IULN.
• Prior treatment with Ixabepilone.
• Strong use of CYPP450 drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

A1

Active Comparator group

Treatment:

Drug: Ixabepilone

Drug: Ixabepilone

Drug: Ixabepilone

A2

Active Comparator group

Treatment:

Drug: Ixabepilone

Drug: Ixabepilone

Drug: Ixabepilone

A3

Active Comparator group

Treatment:

Drug: Ixabepilone

Drug: Ixabepilone

Drug: Ixabepilone