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

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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)

35 participants in 1 patient group

A1
Experimental group
Treatment:
Drug: Ixabepilone

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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