AnemiaPhase 3NCT00110955
Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
A Phase 3 study testing Darbepoetin alfa in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
Trial summary
The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Apr 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
- Subjects with non-myeloid malignancy
- At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
- Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
- Adequate serum folate and vitamin B12
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Of legal age at the time written informed consent is obtained
Who cannot join
- Known history of seizure disorder
- Known primary hematologic disorder causing anemia other than non-myeloid malignancies
- Unstable/uncontrolled cardiac condition
- Clinically significant inflammatory disease
- Other diagnoses not related to the cancer which can cause anemia
- Inadequate renal and liver function
Show all 18Show fewer
- Iron deficiency
- Known positive test for HIV infection
- Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
- Received more than 2 red blood cell (RBC) transfusions within 4 weeks of 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 of study day 1 or any planned erythropoietic therapy between randomization and study day 1
- Other investigational procedures
- Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)
- Pregnant or breast feeding
- Not using adequate contraceptive precautions
- Previously randomized into this study
- Known hypersensitivity to any products to be administered
- Concerns for subject's compliance
About this study
Official title: A Randomized, Double-Blind, Placebo-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 compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
- Conditions
- Anemia, Non-Myeloid Malignancies
- Being tested
- Darbepoetin alfa, Placebo
- Keywords
- Non-myeloid malignancy, Chemotherapy-induced anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Q3W 300 mcg darbepoetin alfa
PlaceboDrug
Q3W dosing of placebo
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa - Group A | Experimental | Not described Receives: Drug: Darbepoetin alfa |
| Placebo- Group B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
Measured: from week 5 to EOTP
Secondary outcomes (13)
Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP
Measured: from week 5 to EOTP
Number of RBC transfusions from week 5 to EOTP
Measured: from week 5 to EOTP
Change in FACT-Fatigue subscale score from baseline to EOTP
Measured: from baseline to EOTP
Change in FACT-G Physical Well-being subscale 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 FACT-G total score 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
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
Change in number of caregiver hours from baseline to EOTP
Measured: from baseline to EOTP
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 posted17 May 2005 (estimated)
- Study startFeb 2004
- Primary completionMar 2005
- Study completionApr 2005
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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110955
- Sponsor's protocol ID
- 20030232
- Status last verified
- Jan 2010
- First submitted
- 16 May 2005
- Last updated
- 15 Jan 2010
- Results posted
- No
Publications
Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164.
PubMed 19601709
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
- ClinicalTrials.gov ID
- NCT00110955
- Acronym / sponsor ID
- 20030232
- Conditions
- Anemia, Non-Myeloid Malignancies
- Keywords
- Non-myeloid malignancy, Chemotherapy-induced anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 17 May 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 compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle 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 - Group A | Experimental | Drug: Darbepoetin alfa |
| Placebo- Group B | 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 (6 listed)
- Subjects with non-myeloid malignancy
- At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
- Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
- Adequate serum folate and vitamin B12
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Key exclusion criteria (18 listed)
- Known history of seizure disorder
- Known primary hematologic disorder causing anemia other than non-myeloid malignancies
- Unstable/uncontrolled cardiac condition
- Clinically significant inflammatory disease
- Other diagnoses not related to the cancer which can cause anemia
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 alfaQ3W 300 mcg darbepoetin alfa | Drug | Darbepoetin alfa - Group A |
| PlaceboQ3W dosing of placebo | Drug | Placebo- Group B |
Primary outcome
Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
Time frame: from week 5 to EOTP
13 secondary outcomes
Incidence of achieving a hemoglobin concentration of greater than or equal to 11 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
Number of RBC transfusions from week 5 to EOTP
Time frame: from week 5 to EOTP
Change in FACT-Fatigue subscale score from baseline to EOTP
Time frame: from baseline to EOTP
Change in FACT-G Physical Well-being subscale 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 FACT-G total score 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
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
Change in number of caregiver hours from baseline to EOTP
Time frame: from baseline to EOTP
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 15 Jan 2010.
- Results publication: PubMed 19601709Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164.
- 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 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 6 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 15 Jan 2010. 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?
Incidence of red blood cell (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 NCT00110955, 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 15 Jan 2010.