Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Solid Malignancies

Treatments: Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162136

CA163-085

Details and patient eligibility

About

The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of a primary solid tumor
• measurable or non-measurable disease
• progressive disease
• men and women greater or equal to 18 years of age.

Exclusion criteria

• women of child bearing potential who are not using birth control
• women who are pregnant or breast feeding
• women with a positive pregnancy test on enrollment
• patients with brain metastasis
• prior treatment with Ixabepilone
• known history of human immunodeficiency virus (HIV)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

A1

Experimental group

Treatment:

Drug: Ixabepilone