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Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Malignancies

Thank you

Trial Information

Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose Limiting Toxicities at Dose Level

Outcome Time Frame:

Measures taken at Cycle 01 (21-day cycle)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-085

NCT ID:

NCT00162136

Start Date:

September 2005

Completion Date:

July 2008

Related Keywords:

  • Solid Malignancies
  • Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
University of MarylandBaltimore, Maryland  21201
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901