A Study of ABT-751 in Patients With Recurrent Breast Canc... | NCT00063102

Studies
A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.

NCT00063102

Sponsor

Abbott

Status

Completed

Last Update Posted

Nov 29, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Breast Cancer

Interventions

ABT-751

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

Nov 2007

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

Nov 2002

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

Jun 19, 2003

First Submission Date that Met QC Criteria

Jun 20, 2003

First Posted Date

Jun 23, 2003Estimated

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

Nov 28, 2007

Last Update Posted Date

Nov 29, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ABT-751	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate in subjects with Breast cancer		1 year

Secondary Outcomes

Measure	Description	Time Frame
Time to Tumor Progression (TTP)		1 year
Survival		2 years
Toxicities associated with treatment administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Stage IIIB or IV breast cancer.
Recurrent tumor after or while on taxane therapy (taxol or taxotere).
Able to tolerate normal activities of daily living.
Adequate bone marrow, kidney and liver function.

Exclusion Criteria

Pregnant or breast feeding.
No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.

Accepts Healthy Volunteers

Sex

Female

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
Helen Eliopoulos, MD	Abbott	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncology-Hematology Group of South Florida		Miami	Florida	33176	United States
Clinical Research Network, Inc.

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C490492	ABT751

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided