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Ixabepilone Administered as an Enteric Coated Formulation.

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT00309049
Collaborator
(none)
30
Enrollment
2
Locations
3
Arms
13
Duration (Months)
15
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Apr 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Ixempra

    		•

    Outcome Measures

    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. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Local Institution Washington District of Columbia United States
    2 Local Institution Detroit Michigan United States

    Sponsors and Collaborators

    • R-Pharm

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00309049
    Other Study ID Numbers:
    • CA163-088
    First Posted:
    Mar 31, 2006
    Last Update Posted:
    Jan 30, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Epothilones

    Study Results

    No Results Posted as of Jan 30, 2017