Ixabepilone Administered as an Enteric Coated Formulation.

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00309049
First received: March 29, 2006
Last updated: February 3, 2010
Last verified: June 2008
  Purpose

The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.


Condition Intervention Phase
Cancer
Drug: Ixabepilone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.

Estimated Enrollment: 30
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Ixabepilone
Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of IV oral and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
Other Name: Ixempra
Active Comparator: A2 Drug: Ixabepilone
Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral IV and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
Other Name: Ixempra
Active Comparator: A3 Drug: Ixabepilone
Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of oral oral and IV dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
Other Name: Ixempra

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309049

Locations
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Michigan
Local Institution
Detroit, Michigan, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00309049     History of Changes
Other Study ID Numbers: CA163-088
Study First Received: March 29, 2006
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014