A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
Sponsors
Source
Amgen
Brief Summary
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every
3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered
as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid
malignancies.
Overall Status
Completed
Start Date
2004-03-01
Completion Date
2005-01-01
Primary Completion Date
2004-12-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) |
from week 5 to EOTP |
Secondary Outcome
Measure |
Time Frame |
|
Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP |
from week 5 to EOTP |
|
Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP |
from week 1 (day 1) to EOTP |
|
Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP |
from week 1 to EOTP |
|
Change in FACT-G Physical Well-being subscale from baseline to EOTP |
from baseline to EOTP |
|
Change in hemoglobin from baseline to EOTP |
from baseline to EOTP |
|
Change in FACT-Fatigue subscale score from baseline to EOTP |
from baseline to EOTP |
|
Change in FACT-G total score from baseline to EOTP |
from baseline to EOTP |
|
Change in EQ-5D Thermometer from baseline to EOTP |
from baseline to EOTP |
|
Change in BSI Anxiety scale score from baseline to EOTP |
from baseline to EOTP |
|
Change in BSI Depression scale score from baseline to EOTP |
from baseline to EOTP |
|
Incidence and severity of adverse events |
throughout study |
|
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study |
at any time on study |
|
Change in number of caregiver hours from baseline to EOTP |
from baseline to EOTP |
|
Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences |
throughout study |
|
Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences |
throughout study |
|
Incidence of a confirmed antibody formation to darbepoetin alfa |
throughout study |
Enrollment
705
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
Arm Group Label
Darbepoetin alfa 2.25 mcg/kg - Group B
Intervention Type
Drug
Intervention Name
Description
Darbepoetin alfa 500mcg Q3W dosing / placebo QW
Arm Group Label
Darbepoetin alfa 500 mcg - Group A
Eligibility
Criteria
Inclusion Criteria:
- Non-myeloid malignancy
- At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless
of schedule
- Eastern Cooperative Oncology Group performance status of 0-2
- Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
- Of legal age at the time written informed consent is obtained
Exclusion Criteria:
- Known history of seizure disorder
- Known primary hematologic disorder, which could cause anemia, other than a non-myeloid
malignancy
- Unstable or uncontrolled disease/condition, related to or affecting cardiac function
- Clinically significant inflammatory disease
- Inadequate renal and/or liver function
- Known positive HIV test
- Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
- Received more than 2 red blood cell (RBC) transfusions within 4 weeks before
randomization or any RBC transfusion within 14 days before randomization, or any
planned RBC transfusion between randomization and study day 1
- Received any erythropoietic therapy within 4 weeks before randomization or any planned
erythropoietic therapy between randomization and study day 1
- Other investigational procedures
- Subject is currently enrolled in or 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
- Not using adequate contraceptive precautions
- Known sensitivity to any of the products to be administered during dosing
- Previously randomized in this study
- Concerns for subject's compliance with protocol procedures
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
MD |
Study Director |
Amgen |
Verification Date
2013-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Darbepoetin alfa
Arm Group
Arm Group Label
Darbepoetin alfa 500 mcg - Group A
Arm Group Type
Experimental
Arm Group Label
Darbepoetin alfa 2.25 mcg/kg - Group B
Arm Group Type
Active Comparator
Results Reference
Citation
Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84.
PMID
16478746
Citation
Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311. doi: 10.1186/1471-2407-9-311.
PMID
19728887
Firstreceived Results Date
N/A
Reference
Citation
Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus ≥ 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13.
PMID
22081263
Removed Countries
Country
Lithuania
Portugal
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
June 30, 2005
Study First Submitted Qc
June 30, 2005
Study First Posted
July 12, 2005
Last Update Submitted
April 25, 2013
Last Update Submitted Qc
April 25, 2013
Last Update Posted
April 29, 2013
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.