Ixabepilone Administered as an Enteric Coated Formulation.

Cancer Clinical Trial

Official title:

An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309049
• Other study ID #: CA163-088
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 29, 2006
• Last updated: January 27, 2017
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2017
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Local Institution	Detroit	Michigan
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
Secondary	Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm