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Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Neoplasms

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Trial Information

Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer


Inclusion Criteria:



- Up to three prior chemotherapy regimens

- Measurable or non-measurable disease

- Available for treatment and follow-up

Exclusion Criteria:

- Neuropathy

- Uncontrolled cardiovascular disease

- Refusal to participate in genetic analysis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Plasma Concentration (Cmax)

Outcome Description:

Cmax was obtained directly from the concentration-time data.

Outcome Time Frame:

Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-102

NCT ID:

NCT00207090

Start Date:

September 2005

Completion Date:

November 2008

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms
  • Neoplasms

Name

Location

The Cleveland Clinic FoundationCleveland, Ohio