NCT00309049

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

March 29, 2006

Last Update Submit

January 27, 2017

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (3)

A1

ACTIVE COMPARATOR
Drug: Ixabepilone

A2

ACTIVE COMPARATOR
Drug: Ixabepilone

A3

ACTIVE COMPARATOR
Drug: Ixabepilone

Interventions

IxabepiloneDRUG

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.

Also known as: Ixempra
A1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG status of 0-2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Washington D.C., District of Columbia, United States

Location

Local Institution

Detroit, Michigan, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ixabepilone

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 31, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

US(2)