Treatment for Patients With Non-Myeloid Malignancies Rece... | NCT00111137

Studies
Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

NCT00111137

Sponsor

Amgen

Status

Completed

Last Update Posted

Feb 28, 2008Estimated

Enrollment

718Actual

Phase

Phase 3

Conditions

Cancer
Non-Myeloid Malignancies

Interventions

rHuEPO
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

Feb 2008

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

Feb 2003

Primary Completion Date

Nov 2003Actual

Completion Date

Apr 2004Actual

First Submitted Date

May 17, 2005

First Submission Date that Met QC Criteria

May 17, 2005

First Posted Date

May 18, 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

Feb 20, 2008

Last Update Posted Date

Feb 28, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

718Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rHuEPO	Active Comparator		Drug: rHuEPO
Darbepoetin alfa	Experimental		Drug: Darbepoetin alfa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rHuEPO	Drug	rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.	rHuEPO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to hematopoietic response during the comparative treatment period		during the comparative treatment period

Secondary Outcomes

Measure	Description	Time Frame
Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)		during the study
Incidence, if any, of neutralizing antibody formation to study drug

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
Karnofsky performance status of greater than or equal to 50%
Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria:

Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
Hematologic disorder previously associated with anemia
Active bleeding
Iron deficiency
Received erythropoietic therapy within 14 days prior to randomization
Unstable cardiac disease
Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
Known positive antibody response to any erythropoietic agent
Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
Pregnant or breast feeding
Red blood cell (RBC) transfusion within 4 weeks of screening
Known hypersensitivity to any recombinant mammalian-derived product

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

ID	Term
D009369	Neoplasms
D000740	Anemia

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

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