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An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.


Inclusion Criteria:



- ECOG status of 0-2.

Exclusion Criteria:

- Unable to swallow pills.

- Current or recent GI disease or GI surgery.

- Brain mets.

- Severe nerve damage.

- ANC <1,500/mm3

- Platelets <125K.

- Bilirubin >=1.5 times the IULN.

- ALT/AST >=1.5 times the IULN.

- Creatine >1.5 times the IULN.

- Prior treatment with Ixabepilone.

- Strong use of CYPP450 drugs.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-088

NCT ID:

NCT00309049

Start Date:

April 2006

Completion Date:

May 2007

Related Keywords:

  • Cancer

Name

Location

Local InstitutionWashington, District of Columbia  
Local InstitutionDetroit, Michigan