NeoplasmsPhase 3NCT00038064
Anemia in Patients With a Non-Myeloid Malignancy
A Phase 3 study testing Darbepoetin alfa and rHuEPO in people with Neoplasms and Anemia, run by Amgen.
Trial summary
Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Darbepoetin alfa and rHuEPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 707 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Apr 2004
- 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
- Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
- Screening hemoglobin concentration less than or equal to 11.0 g/dL
- ECOG performance status of 0 to 2 (inclusive)
Who cannot join
- History of seizure disorder
- Primary hematologic disorder that could cause anemia
- Unstable or uncontrolled disease/condition related to or affecting cardiac function
- Clinical evidence of chronic infection/inflammatory disease
- Positive test for HIV infection
- Previously confirmed neutralizing antibodies to rHuEPO
- Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences
About this study
Official title: A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.
- Being tested
- Darbepoetin alfa, rHuEPO
- Keywords
- anemia of cancer/chemotherapy, non-myeloid malignancies, Drug Therapy
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.
rHuEPODrug
150 IU/kg TIW
| Study group | Role | What they receive |
|---|---|---|
| rHuEPO | Active comparator | Not described Receives: Drug: rHuEPO |
| Darbepoetin alfa | Experimental | Not described Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first hemoglobin response during the treatment period
Measured: during the treatment period
Secondary outcomes (16)
Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
Measured: throughout study
Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
Measured: throughout study
Average weekly dosage of study drug during the 16-week treatment period
Measured: 16-week treatment period
Receiving red blood cell (RBC) transfusion from week 5 to week 12
Measured: from week 5 to week 12
Change in FACT-Fatigue scale score from baseline to week 7
Measured: from baseline to week 7
Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise
Measured: throughout study
Profile of change in FACT-Fatigue scale score from baseline over the treatment period
Measured: from baseline over the treatment period
Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
Measured: from baseline to EOTP
Change in FACT-Physical Well-being scale score from baseline to EOTP
Measured: from baseline to EOTP
Receiving RBC transfusion during the treatment period
Measured: during the treatment period
Number of units of RBC transfused during the treatment period
Measured: during the treatment period
Achieving a hemoglobin response by week 7
Measured: baseline to week 7
Change in hemoglobin concentration from baseline to EOTP
Measured: from baseline to EOTP
Time to first hematopoietic response
Measured: throughout study
Achieving a hemoglobin correction
Measured: throughout study
Number and percentage of subjects who exceed the hemoglobin concentration threshold
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 posted29 May 2002 (estimated)
- Study startJan 2002
- Primary completionOct 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- None (open label)
- Enrolment
- 707 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
- NCT00038064
- Sponsor's protocol ID
- 20010101
- Status last verified
- Sep 2008
- First submitted
- 28 May 2002
- Last updated
- 15 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
- ClinicalTrials.gov ID
- NCT00038064
- Acronym / sponsor ID
- 20010101
- Keywords
- anemia of cancer/chemotherapy, non-myeloid malignancies, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 29 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.
Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rHuEPO | Active comparator | Drug: rHuEPO |
| Darbepoetin alfa | Experimental | Drug: Darbepoetin alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
- Screening hemoglobin concentration less than or equal to 11.0 g/dL
- ECOG performance status of 0 to 2 (inclusive)
Key exclusion criteria (7 listed)
- History of seizure disorder
- Primary hematologic disorder that could cause anemia
- Unstable or uncontrolled disease/condition related to or affecting cardiac function
- Clinical evidence of chronic infection/inflammatory disease
- Positive test for HIV infection
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 alfaDarbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W. | Drug | Darbepoetin alfa |
| rHuEPO150 IU/kg TIW | Drug | rHuEPO |
Primary outcome
Time to first hemoglobin response during the treatment period
Time frame: during the treatment period
16 secondary outcomes
Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
Time frame: throughout study
Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
Time frame: throughout study
Average weekly dosage of study drug during the 16-week treatment period
Time frame: 16-week treatment period
Receiving red blood cell (RBC) transfusion from week 5 to week 12
Time frame: from week 5 to week 12
Change in FACT-Fatigue scale score from baseline to week 7
Time frame: from baseline to week 7
Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise
Time frame: throughout study
Profile of change in FACT-Fatigue scale score from baseline over the treatment period
Time frame: from baseline over the treatment period
Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
Time frame: from baseline to EOTP
Change in FACT-Physical Well-being scale score from baseline to EOTP
Time frame: from baseline to EOTP
Receiving RBC transfusion during the treatment period
Time frame: during the treatment period
Number of units of RBC transfused during the treatment period
Time frame: during the treatment period
Achieving a hemoglobin response by week 7
Time frame: baseline to week 7
Change in hemoglobin concentration from baseline to EOTP
Time frame: from baseline to EOTP
Time to first hematopoietic response
Time frame: throughout study
Achieving a hemoglobin correction
Time frame: throughout study
Number and percentage of subjects who exceed the hemoglobin concentration threshold
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 Sep 2008.
- 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 and rHuEPO in people with Neoplasms and Anemia, 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 3 inclusion and 7 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 Sep 2008. 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?
Time to first hemoglobin response during the treatment period (time frame: during the treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2008.