Darbepoetin Alfa Administered Once Every 4 Weeks in the T... | NCT00095277

Studies
Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

NCT00095277

Sponsor

Amgen

Status

Completed

Last Update Posted

Mar 13, 2009Estimated

Enrollment

220

Phase

Phase 2

Conditions

Anemia

Interventions

Darbepoetin Alfa

Countries

Not provided

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 2004

First Submission Date that Met QC Criteria

Nov 2, 2004

First Posted Date

Nov 3, 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

Mar 12, 2009

Last Update Posted Date

Mar 13, 2009Estimated

Description Module

Brief Summary

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

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

220

Name	Type	Description	Arm Group Labels	Other Names
Darbepoetin Alfa	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Assess efficacy
Assess PROs
Assess relationship between PROs and hemoglobin concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent

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

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18586927	Result	Gordon D, Nichols G, Ben-Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study. Oncologist. 2008 Jun;13(6):715-24. doi: 10.1634/theoncologist.2007-0241.

ID	Term
D000740	Anemia
D054219	Neoplasms, Plasma Cell

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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