AnemiaPhase 3NCT00118638
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
A Phase 3 study testing Darbepoetin alfa - 2.25 mcg/kg and Darbepoetin alfa - 500mcg in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Non-Myeloid Malignancies
- What is being tested?
- Darbepoetin alfa - 2.25 mcg/kg and Darbepoetin alfa - 500mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
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.
- Conditions
- Anemia, Non-Myeloid Malignancies
- Being tested
- Darbepoetin alfa - 2.25 mcg/kg, Darbepoetin alfa - 500mcg
- Keywords
- Non-myeloid malignancy, Darbepoetin alfa, Clinical Trial
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfa - 2.25 mcg/kgDrug
Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
Darbepoetin alfa - 500mcgDrug
Darbepoetin alfa 500mcg Q3W dosing / placebo QW
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa 500 mcg - Group A | Experimental | Not described Receives: Drug: Darbepoetin alfa - 500mcg |
| Darbepoetin alfa 2.25 mcg/kg - Group B | Active comparator | Not described Receives: Drug: Darbepoetin alfa - 2.25 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)
Measured: from week 5 to EOTP
Secondary outcomes (16)
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
Measured: from week 5 to EOTP
Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP
Measured: 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
Measured: from week 1 to EOTP
Change in FACT-G Physical Well-being subscale from baseline to EOTP
Measured: from baseline to EOTP
Change in hemoglobin from baseline to EOTP
Measured: from baseline to EOTP
Change in FACT-Fatigue subscale score from baseline to EOTP
Measured: from baseline to EOTP
Change in FACT-G total score from baseline to EOTP
Measured: from baseline to EOTP
Change in EQ-5D Thermometer from baseline to EOTP
Measured: from baseline to EOTP
Change in BSI Anxiety scale score from baseline to EOTP
Measured: from baseline to EOTP
Change in BSI Depression scale score from baseline to EOTP
Measured: from baseline to EOTP
Incidence and severity of adverse events
Measured: throughout study
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
Measured: at any time on study
Change in number of caregiver hours from baseline to EOTP
Measured: 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
Measured: 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
Measured: throughout study
Incidence of a confirmed antibody formation to darbepoetin alfa
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startMar 2004
- Primary completionDec 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118638
- Sponsor's protocol ID
- 20030231
- Status last verified
- Apr 2013
- First submitted
- 30 Jun 2005
- Last updated
- 29 Apr 2013
- Results posted
- No
Publications
Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B,
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.
PubMed 22081263Canon 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. doi: 10.1093/jnci/djj053.
PubMed 16478746Vansteenkiste 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.
PubMed 19728887
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
- ClinicalTrials.gov ID
- NCT00118638
- Acronym / sponsor ID
- 20030231
- Conditions
- Anemia, Non-Myeloid Malignancies
- Keywords
- Non-myeloid malignancy, Darbepoetin alfa, Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa 500 mcg - Group A | Experimental | Drug: Darbepoetin alfa - 500mcg |
| Darbepoetin alfa 2.25 mcg/kg - Group B | Active comparator | Drug: Darbepoetin alfa - 2.25 mcg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin alfa - 2.25 mcg/kgDarbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W | Drug | Darbepoetin alfa 2.25 mcg/kg - Group B |
| Darbepoetin alfa - 500mcgDarbepoetin alfa 500mcg Q3W dosing / placebo QW | Drug | Darbepoetin alfa 500 mcg - Group A |
Primary outcome
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)
Time frame: from week 5 to EOTP
16 secondary outcomes
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
Time frame: from week 5 to EOTP
Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP
Time frame: 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
Time frame: from week 1 to EOTP
Change in FACT-G Physical Well-being subscale from baseline to EOTP
Time frame: from baseline to EOTP
Change in hemoglobin from baseline to EOTP
Time frame: from baseline to EOTP
Change in FACT-Fatigue subscale score from baseline to EOTP
Time frame: from baseline to EOTP
Change in FACT-G total score from baseline to EOTP
Time frame: from baseline to EOTP
Change in EQ-5D Thermometer from baseline to EOTP
Time frame: from baseline to EOTP
Change in BSI Anxiety scale score from baseline to EOTP
Time frame: from baseline to EOTP
Change in BSI Depression scale score from baseline to EOTP
Time frame: from baseline to EOTP
Incidence and severity of adverse events
Time frame: throughout study
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
Time frame: at any time on study
Change in number of caregiver hours from baseline to EOTP
Time frame: 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
Time frame: 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
Time frame: throughout study
Incidence of a confirmed antibody formation to darbepoetin alfa
Time frame: throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
- BackgroundCanon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B,
- Results publication: PubMed 22081263Canon 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.
- Results publication: PubMed 16478746Canon 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. doi: 10.1093/jnci/djj053.
- Results publication: PubMed 19728887Vansteenkiste 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin alfa - 2.25 mcg/kg and Darbepoetin alfa - 500mcg in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) (time frame: from week 5 to EOTP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00118638, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.