Study of Darbepoetin Alfa for the Treatment of Anemia of... | NCT00091858

Studies
Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

NCT00091858

Sponsor

Amgen

Status

Completed

Last Update Posted

May 8, 2013Estimated

Enrollment

1,000

Phase

Phase 3

Conditions

Anemia
Cancer

Interventions

Darbepoetin Alfa
Placebo

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

May 2013

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 2004

Primary Completion Date

Oct 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Sep 17, 2004

First Submission Date that Met QC Criteria

Sep 20, 2004

First Posted Date

Sep 21, 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

May 6, 2013

Last Update Posted Date

May 8, 2013Estimated

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

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000

Label	Type	Description	Intervention Names
Darbepoetin alfa 6.75 mcg/kg Q4W	Experimental		Drug: Darbepoetin Alfa
Placebo Q4W	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Darbepoetin Alfa	Drug	6.75 mcg/kg Q4W	Darbepoetin alfa 6.75 mcg/kg Q4W

Measure	Description	Time Frame
Occurrences of red blood cell transfusion		from study day 29 (week 5) to week 17

Measure	Description	Time Frame
Incidence of first red blood cell transfusion		from week 5 (study day 29) to week 17 (study day 119)
Change in hemoglobin concentration measured		from baseline (study day 1) to EOTP

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects with non-myeloid malignancies
anemia due to cancer
ECOG status 0 to 2
greater than or equal to 4-month expectancy
greater than or equal to 18 years and of legal age for informed consent
screening hemoglobin concentration less than or equal to 11.0g/dL
adequate serum folate and vitamin B12
adequate renal and liver function
written informed consent

Exclusion Criteria:

subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
in complete remission, as determined by the investigator
subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
documented history of pure red cell aplasia
Known history of seizure disorder
cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
uncontrolled hypertension
clinically significant systemic infection or chronic inflammatory disease present at the time of randomization
iron deficiency
known positive test for HIV infection
previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
pregnant or breast feeding
subject of reproductive potential who is not using adequate contraceptive precautions
known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
previously randomized into this study
concerns for subject's compliance with the protocol procedures

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
18227526	Result	Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.

ID	Term
D000740	Anemia
D009369	Neoplasms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

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