AnemiaPhase 3NCT00091858
Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
A Phase 3 study testing Darbepoetin Alfa in people with Anemia and Cancer, run by Amgen.
Trial summary
The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Darbepoetin Alfa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Dec 2006
- 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
- 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
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- adequate serum folate and vitamin B12
- adequate renal and liver function
- written informed consent
Who cannot join
- 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
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- 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
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.
- Being tested
- Darbepoetin Alfa, Placebo
- Keywords
- Cancer-related anemia
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin AlfaDrug
6.75 mcg/kg Q4W
PlaceboDrug
Placebo Q4W
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa 6.75 mcg/kg Q4W | Experimental | Not described Receives: Drug: Darbepoetin Alfa |
| Placebo Q4W | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of red blood cell transfusion
Measured: from study day 29 (week 5) to week 17
Secondary outcomes (5)
Incidence of first red blood cell transfusion
Measured: from week 5 (study day 29) to week 17 (study day 119)
Change in hemoglobin concentration measured
Measured: from baseline (study day 1) to EOTP
Adverse events and serious adverse events
Measured: throughout study for subjects who received at least 1 dose of investigational product
Survival
Measured: deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product
Incidence, if any, of neutralizing antibody formation to investigational product
Measured: throughout study for subjects who received at least 1 dose of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2004 (estimated)
- Study startApr 2004
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 1,000 participants
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
- NCT00091858
- Sponsor's protocol ID
- 20010103
- Status last verified
- May 2013
- First submitted
- 17 Sep 2004
- Last updated
- 8 May 2013
- Results posted
- No
Publications
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.
PubMed 18227526
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
- ClinicalTrials.gov ID
- NCT00091858
- Acronym / sponsor ID
- 20010103
- Keywords
- Cancer-related anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2004 (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 versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.
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 6.75 mcg/kg Q4W | Experimental | Drug: Darbepoetin Alfa |
| Placebo Q4W | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 Alfa6.75 mcg/kg Q4W | Drug | Darbepoetin alfa 6.75 mcg/kg Q4W |
| PlaceboPlacebo Q4W | Drug | Placebo Q4W |
Primary outcome
Occurrences of red blood cell transfusion
Time frame: from study day 29 (week 5) to week 17
5 secondary outcomes
Incidence of first red blood cell transfusion
Time frame: from week 5 (study day 29) to week 17 (study day 119)
Change in hemoglobin concentration measured
Time frame: from baseline (study day 1) to EOTP
Adverse events and serious adverse events
Time frame: throughout study for subjects who received at least 1 dose of investigational product
Survival
Time frame: deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product
Incidence, if any, of neutralizing antibody formation to investigational product
Time frame: throughout study for subjects who received at least 1 dose of investigational product
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 8 May 2013.
- Results publication: PubMed 18227526Smith 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.
- 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 in people with Anemia and Cancer, 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 9 inclusion and 18 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 8 May 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. Some participants in this study may receive a placebo. 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?
Occurrences of red blood cell transfusion (time frame: from study day 29 (week 5) to week 17). 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 NCT00091858, which also lists 1 linked publication.
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 8 May 2013.