Treatment of Anemic Patients With Cancer Who Are Not Rece... | NCT00083434

Studies
Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy

NCT00083434

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Status

Terminated

Last Update Posted

Apr 27, 2011Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Anemia
Cancer

Interventions

Epoetin alfa

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

ID	Type	Description	Link
EPO-CAN-303

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was stopped because of an inadequate rate of enrollment.

Expanded Access Info

Not provided

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Oct 2004Actual

First Submitted Date

May 24, 2004

First Submission Date that Met QC Criteria

May 25, 2004

First Posted Date

May 26, 2004Estimated

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

Apr 25, 2011

Last Update Posted Date

Apr 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.

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 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Epoetin alfa	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Body weight >/= 99lbs
ECOG 0-2
Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
Screening hemoglobin level of \

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Urology Medical Center		Anaheim	California	92801	United States
Shapiro, Stafford & Yee

References Module

Citations

Not provided

Label	URL
FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/	View source
Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm	View source

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

ID	Term
D000740	Anemia
D009369	Neoplasms