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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014