ClinicalTrials.gov
ClinicalTrials.gov Menu

Ixabepilone Administered as an Enteric Coated Formulation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00309049
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : January 30, 2017
Sponsor:
Information provided by:
R-Pharm

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

Condition or disease Intervention/treatment Phase
Cancer Drug: Ixabepilone Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.
Study Start Date : April 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ixabepilone

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
R-Pharm
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00309049     History of Changes
Other Study ID Numbers: CA163-088
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

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