Ixabepilone Administered as an Enteric Coated Formulation. | NCT00309049

Studies
Ixabepilone Administered as an Enteric Coated Formulation.

NCT00309049

Sponsor

R-Pharm

Status

Completed

Last Update Posted

Jan 30, 2017Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Cancer

Interventions

Ixabepilone
Ixabepilone
Ixabepilone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Mar 29, 2006

First Submission Date that Met QC Criteria

Mar 30, 2006

First Posted Date

Mar 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A1	Active Comparator	Drug: Ixabepilone
A2	Active Comparator	Drug: Ixabepilone
A3	Active Comparator	Drug: Ixabepilone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ixabepilone	Drug	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Washington D.C.	District of Columbia		United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C430592	ixabepilone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided