AnemiaPhase 2NCT00035607
Chemotherapy Related Anemia
A Phase 2 study testing Darbepoetin alfa SC and Darbepoetin alfa IV in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
Trial summary
This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. 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 SC and Darbepoetin alfa IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Apr 2003
- Phase
- Phase 2
- 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
- Diagnosed with a non-myeloid malignancy
- Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
- Screening hemoglobin concentration less than or equal to 11.0g/dL
- ECOG performance status of 0 to 2
- Adequate renal and liver function
Who cannot join
- History of seizure disorder
- Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
- More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
About this study
Official title: A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).
- Conditions
- Anemia, Non-Myeloid Malignancies
- Being tested
- Darbepoetin alfa SC, Darbepoetin alfa IV
- 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 SCDrug
Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
Darbepoetin alfa IVDrug
Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa SC | Active comparator | Not described Receives: Drug: Darbepoetin alfa SC |
| Darbepoetin alfa IV | Experimental | Not described Receives: Drug: Darbepoetin alfa IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
Measured: from baseline to the end of treatment period (EOTP)
Secondary outcomes (7)
Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
Measured: throughout study
Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
Measured: from baseline to week 7 and from week 7 to EOTP
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
Measured: during the treatment period
Time to and percentage of subjects with a hemoglobin response during the treatment period
Measured: during the treatment period
Percentage of subjects who exceed the hemoglobin threshold
Measured: throughout study
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
Measured: throughout study
Incidence, if any, of neutralizing 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 posted6 May 2002 (estimated)
- Study startDec 2001
- Primary completionDec 2002
- Study completionApr 2003
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT00035607
- Sponsor's protocol ID
- 20010199
- Status last verified
- May 2013
- First submitted
- 3 May 2002
- Last updated
- 13 May 2013
- Results posted
- No
Publications
Justice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28.
PubMed 15860486
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
- ClinicalTrials.gov ID
- NCT00035607
- Acronym / sponsor ID
- 20010199
- Conditions
- Anemia, Non-Myeloid Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 6 May 2002 (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.
This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa SC | Active comparator | Drug: Darbepoetin alfa SC |
| Darbepoetin alfa IV | Experimental | Drug: Darbepoetin alfa IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with a non-myeloid malignancy
- Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
- Screening hemoglobin concentration less than or equal to 11.0g/dL
- ECOG performance status of 0 to 2
- Adequate renal and liver function
Key exclusion criteria (3 listed)
- History of seizure disorder
- Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
- More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
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 SCSubcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W | Drug | Darbepoetin alfa SC |
| Darbepoetin alfa IVIntravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W | Drug | Darbepoetin alfa IV |
Primary outcome
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
Time frame: from baseline to the end of treatment period (EOTP)
7 secondary outcomes
Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
Time frame: throughout study
Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
Time frame: from baseline to week 7 and from week 7 to EOTP
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
Time frame: during the treatment period
Time to and percentage of subjects with a hemoglobin response during the treatment period
Time frame: during the treatment period
Percentage of subjects who exceed the hemoglobin threshold
Time frame: throughout study
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
Time frame: throughout study
Incidence, if any, of neutralizing 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 13 May 2013.
- Results publication: PubMed 15860486Justice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 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 2 study testing Darbepoetin alfa SC and Darbepoetin alfa IV 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 3 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 13 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) (time frame: from baseline to the end of treatment period (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 NCT00035607, 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 13 May 2013.