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A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer


Inclusion Criteria:



- ECOG status of 0-1

Exclusion Criteria:

- Inability to tolerate venous access

- Brain mets

- Severe nerve damage

- ANC <2,000/mm3

- Platelets <100K

- Bilirubin >= 1.5 times the IULN

- ALT/AST >= 2.5 times the IULN

- Creatinine <50 mL/min

- Prior treatment with vinflunine and/or ixabepilone

- Strong use of CYPP450 drugs

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.

Outcome Time Frame:

upon occurrence

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:

CA183-008

NCT ID:

NCT00362830

Start Date:

August 2006

Completion Date:

September 2007

Related Keywords:

  • Cancer

Name

Location

The Cleveland Clinic FoundationCleveland, Ohio  
University Of Miami Miller School Of MedicineMiami, Florida  33010