A Long Term Safety Study With Atrasentan | NCT00127478

Studies
A Long Term Safety Study With Atrasentan

NCT00127478

Sponsor

Abbott

Status

Completed

Last Update Posted

Nov 29, 2007Estimated

Enrollment

166Actual

Phase

Phase 2Phase 3

Conditions

Prostate Cancer
Adenocarcinoma

Interventions

Atrasentan

Countries

United States
Canada
France
Netherlands
United Kingdom

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

Jul 2001

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Aug 4, 2005

First Submission Date that Met QC Criteria

Aug 4, 2005

First Posted Date

Aug 8, 2005Estimated

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

Description Module

Brief Summary

The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Name	Type	Description	Arm Group Labels	Other Names
Atrasentan	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		Every 12 weeks
Serious adverse events
Oncology-related events (OREs)
Deaths
Study drug exposure
Change from baseline in Karnofsky performance status
Vital signs
Stratification by treatment group from prior study

Secondary Outcomes

Measure	Description	Time Frame
Safety and laboratory parameters		Every 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Greater than or equal to 18 years, inclusive;
Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
Karnofsky Performance Score greater than or equal to 60;
Adequate hematologic function and liver function tests;
No New York Heart Association (NYHA) class greater than or equal to 2.

Accepts Healthy Volunteers

Sex

Male

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
Gary Gordon, MD	Abbott	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prostate Oncology Specialists		Marina del Rey	California	32589	United States
Western Clinical Research, Inc.

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D000230	Adenocarcinoma

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077868	Atrasentan

Ancestor Terms

ID	Term
D052117	Benzodioxoles
D004149	Dioxoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided