AnemiaPhase 2NCT00540696
Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa
A Phase 2 study testing darbepoetin alfa in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
Trial summary
The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid 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?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Sep 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
- Non-myeloid malignancies
- Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy
- Plan to receive cyclic chemotherapy for an additional 8 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate renal and liver function
- Ability to participate in the MHST based on clinical judgement of investigator
- At least 18 years of age
Who cannot join
- Iron deficiency
- Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment
- Unstable cardiac disease
- Current active condition creating clinical danger for the subject to participate in the MHST
- known positive test for HIV infection
- Previous hematologic disorder associated with anemia
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- Currently receiving beta-blockers
- Use of drugs or devices not approved by the FDA for any indication
- Pregnant or breast feeding
- Known hypersensitivity to any recombinant mammalian-derived product
About this study
Official title: An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)
The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy.
Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.
- Conditions
- Anemia, Non-Myeloid Malignancies
- Being tested
- darbepoetin alfa
- Keywords
- Anemia, Non-Myeloid Malignancies, darbepoetin alfa, chemotherapy
- 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
Darbepoetin alfa 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses.
Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses.
| Study group | Role | What they receive |
|---|---|---|
| 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.
Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score
Measured: baseline
Relationship between hemoglobin (hgb) response and change in functional capacity
Measured: week 1, week 9, week 17
Secondary outcomes (12)
Estimates of the sensitivity and specificity of the FCST
Relationship between hgb variables and changes on the MHST score, the FCST and its components
Measured: from baseline to end of treatment phase
Maximum change in hgb from baseline to any point during the study, excluding hgb measurements obtained within 28 days of a red blood cell (RBC) transfusion
Measured: from baseline to any point during the study
Number and proportion of subjects who achieve a hgb response as defined by an increase of greater than or equal to 2.0 g/dL from the baseline hgb in absence of any RBC transfusion within the prior 28 days at any point during the study (hgb response)
Measured: from baseline to any point during the study
Hgb improvement (defined as correction and/or response)
Measured: from baseline to any point during the study
Change in hgb from baseline to week 17, or the subject's last hgb value excluding hgb measurements obtained within 28 days of a RBC transfusion
Measured: from baseline to week 17
Number and proportion of subjects who receive any RBC transfusions, the number of units of RBC transfused, and the number of days with at least 1 RBC transfusion from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase
Measured: from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase
Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events
Measured: throughout the study
Safety of darbepoetin alfa as determined by antibody formation
Measured: throughout the study
Changes in concomitant medications
Measured: throughout the study
Rapid rise in hgb (a greater than or equal to 2.0 g/dL increase in hgb concentration within a 28-day window during the treatment period)
Measured: within a 28-day window during the treatment period
Proportion of subjects who achieve a hgb of greater than or equal to 12.0 g/dL at any point during the study (hgb correction)
Measured: at any point during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startSep 2001
- Primary completionJun 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540696
- Sponsor's protocol ID
- 20000220
- Status last verified
- Apr 2013
- First submitted
- 4 Oct 2007
- Last updated
- 26 Apr 2013
- Results posted
- No
Publications
Vadhan-Raj S, Mirtsching B, Charu V, Terry D, Rossi G, Tomita D, McGuire WP. Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J Support Oncol. 2003 Jul-Aug;1(2):131-8.
PubMed 15352656Kallich J, McDermott A, Xu X, Fayers P, Cella D. The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res. 2006 Feb;15(1):57-68. doi: 10.1007/s11136-005-8324-0.
PubMed 16411031Cella D, Viswanathan HN, Hays RD, Mendoza TR, Stein KD, Pasta DJ, Foreman AJ, Vadhan-Raj S, Kallich JD. Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy. Cancer. 2008 Sep 15;113(6):1480-8. doi: 10.1002/cncr.23698.
PubMed 18642348
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)
- ClinicalTrials.gov ID
- NCT00540696
- Acronym / sponsor ID
- 20000220
- Conditions
- Anemia, Non-Myeloid Malignancies
- Keywords
- Anemia, Non-Myeloid Malignancies, darbepoetin alfa, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 8 Oct 2007 (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 develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy.
Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 (7 listed)
- Non-myeloid malignancies
- Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy
- Plan to receive cyclic chemotherapy for an additional 8 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate renal and liver function
Key exclusion criteria (10 listed)
- Iron deficiency
- Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment
- Unstable cardiac disease
- Current active condition creating clinical danger for the subject to participate in the MHST
- known 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 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses. Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses. | Drug | darbepoetin alfa |
Primary outcome
Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score
Time frame: baseline
Relationship between hemoglobin (hgb) response and change in functional capacity
Time frame: week 1, week 9, week 17
12 secondary outcomes
Estimates of the sensitivity and specificity of the FCST
Relationship between hgb variables and changes on the MHST score, the FCST and its components
Time frame: from baseline to end of treatment phase
Maximum change in hgb from baseline to any point during the study, excluding hgb measurements obtained within 28 days of a red blood cell (RBC) transfusion
Time frame: from baseline to any point during the study
Number and proportion of subjects who achieve a hgb response as defined by an increase of greater than or equal to 2.0 g/dL from the baseline hgb in absence of any RBC transfusion within the prior 28 days at any point during the study (hgb response)
Time frame: from baseline to any point during the study
Hgb improvement (defined as correction and/or response)
Time frame: from baseline to any point during the study
Change in hgb from baseline to week 17, or the subject's last hgb value excluding hgb measurements obtained within 28 days of a RBC transfusion
Time frame: from baseline to week 17
Number and proportion of subjects who receive any RBC transfusions, the number of units of RBC transfused, and the number of days with at least 1 RBC transfusion from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase
Time frame: from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase
Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events
Time frame: throughout the study
Safety of darbepoetin alfa as determined by antibody formation
Time frame: throughout the study
Changes in concomitant medications
Time frame: throughout the study
Rapid rise in hgb (a greater than or equal to 2.0 g/dL increase in hgb concentration within a 28-day window during the treatment period)
Time frame: within a 28-day window during the treatment period
Proportion of subjects who achieve a hgb of greater than or equal to 12.0 g/dL at any point during the study (hgb correction)
Time frame: at any point during the 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 26 Apr 2013.
- Results publication: PubMed 15352656Vadhan-Raj S, Mirtsching B, Charu V, Terry D, Rossi G, Tomita D, McGuire WP. Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J Support Oncol. 2003 Jul-Aug;1(2):131-8.
- Results publication: PubMed 16411031Kallich J, McDermott A, Xu X, Fayers P, Cella D. The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res. 2006 Feb;15(1):57-68. doi: 10.1007/s11136-005-8324-0.
- Results publication: PubMed 18642348Cella D, Viswanathan HN, Hays RD, Mendoza TR, Stein KD, Pasta DJ, Foreman AJ, Vadhan-Raj S, Kallich JD. Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy. Cancer. 2008 Sep 15;113(6):1480-8. doi: 10.1002/cncr.23698.
- AmgenTrials clinical trials websiteLink 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 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 7 inclusion and 10 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 26 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 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?
Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT00540696, which also lists 3 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 26 Apr 2013; AzTrials last refreshed its copy on 28 Oct 2026.