AnemiaPhase 2NCT00989092

Darbepoetin Alfa and Anemia of Cancer

A Phase 2 study testing darbepoetin alfa in people with Anemia and Anemia of Cancer, run by Amgen.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Anemia of Cancer, Cancer
What is being tested?: darbepoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 287 participants
Where: No sites listed yet
Study dates: May 2002to Jun 2004
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

nonmyeloid malignancies (including lymphocytic leukemias)
anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
Eastern Cooperative Oncology Group performance status of 0 to 2
adequate liver and renal functions
18 years or older

Who cannot join

history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
known hematologic disorders that could cause anemia
inflammatory or cardiac disorders
previous positive antibody response to any erythropoietic agent
history of pure red cell aplasia

About this study

Official title: A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer

This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).

Conditions: Anemia, Anemia of Cancer, Cancer, Carcinoma, Neoplasms, Non-Myeloid Malignancies
Being tested: darbepoetin alfa
Keywords: anemia of cancer, darbepoetin alfa, Aranesp
Medical subject headings: Anemia, Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

darbepoetin alfaBiological
Also called Aranesp®
Administered subcutaneously.

Study groups in NCT00989092
Study group	Role	What they receive
Observational Group	Other	Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Receives: Biological: darbepoetin alfa
21 week treatment group	Active comparator	Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7. Receives: Biological: darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Hospitalized During the Test Period
Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
Measured: Weeks 1- 12
Days of Hospitalization During the Test Period
Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.
Measured: Weeks 1-12
Number of Hospitalizations During the Test Period
Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
Measured: Weeks 1-12

Secondary outcomes (11)

Total Hospital Costs During the Test Period
The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.
Measured: Weeks 1-12
Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.
Measured: Baseline (Week 1) and Week 13
Hemoglobin Response During the Test Period
The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
Measured: Weeks 1-12
Hematopoietic Response During the Test Period
The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
Measured: Weeks 1-12
Change From Baseline in Hemoglobin Level
The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).
Measured: Baseline (Week 1) and Week 13
Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
Number of participants with at least one RBC transfusion during Weeks 1 to 12.
Measured: Weeks 1-12
Number of Units of Red Blood Cells Transfused During the Test Period
The average number of standard units of red blood cells transfused during Weeks 1 to 12.
Measured: Weeks 1-12
Number of Days of Red Blood Cell Transfusions During the Test Period
The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.
Measured: Weeks 1-12
Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
The number of participants with at least one RBC transfusion during weeks 5 to 12.
Measured: Weeks 5-12
Number of Units of Red Blood Cells Transfused During Weeks 5-12
The number of standard units of RBCs transfused during Weeks 5 to 12.
Measured: Weeks 5-12
Number of Days of Red Blood Cell Transfusions During Weeks 5-12
The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
Measured: Weeks 5-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2002Jun 2004

First posted2 Oct 2009 (estimated)
Study startMay 2002
Primary completionJan 2004
Study completionJun 2004

Why it stopped: slow enrollment and change in product development strategy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00989092
Sponsor's protocol ID: 20000219
Status last verified: Dec 2013
First submitted: 1 Oct 2009
Last updated: 29 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Charu V, Belani CP, Gill AN, Bhatt M, Tomita D, Rossi G, Ben-Jacob A. Efficacy and safety of every-2-week darbepoetin alfa in patients with anemia of cancer: a controlled, randomized, open-label phase II trial. Oncologist. 2007 Jun;12(6):727-37. doi: 10.1634/theoncologist.12-6-727.
PubMed 17602062

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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RecruitingObservational study
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer
ClinicalTrials.gov ID: NCT00989092
Acronym / sponsor ID: 20000219
Conditions: Anemia, Anemia of Cancer, Cancer, Carcinoma, Neoplasms, Non-Myeloid Malignancies
Keywords: anemia of cancer, darbepoetin alfa, Aranesp
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow enrollment and change in product development strategy
Enrolment: 287 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: May 2002
Primary completion: Jan 2004 (actual)
Study completion: Jun 2004 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Posted 29 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Observational Group	Other	Biological: darbepoetin alfaParticipants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
21 week treatment group	Active comparator	Biological: darbepoetin alfaParticipants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

nonmyeloid malignancies (including lymphocytic leukemias)
anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
Eastern Cooperative Oncology Group performance status of 0 to 2
adequate liver and renal functions
18 years or older

Key exclusion criteria (6 listed)

history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
known hematologic disorders that could cause anemia
inflammatory or cardiac disorders
previous positive antibody response to any erythropoietic agent

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 alfaAlso: Aranesp®Administered subcutaneously.	Biological	21 week treatment group, Observational Group

Primary outcome

Number of Participants Hospitalized During the Test Period
Time frame: Weeks 1- 12
Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
Days of Hospitalization During the Test Period
Time frame: Weeks 1-12
Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.
Number of Hospitalizations During the Test Period
Time frame: Weeks 1-12
Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12

11 secondary outcomes

Total Hospital Costs During the Test Period
Time frame: Weeks 1-12
Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
Time frame: Baseline (Week 1) and Week 13
Hemoglobin Response During the Test Period
Time frame: Weeks 1-12
Hematopoietic Response During the Test Period
Time frame: Weeks 1-12
Change From Baseline in Hemoglobin Level
Time frame: Baseline (Week 1) and Week 13
Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
Time frame: Weeks 1-12
Number of Units of Red Blood Cells Transfused During the Test Period
Time frame: Weeks 1-12
Number of Days of Red Blood Cell Transfusions During the Test Period
Time frame: Weeks 1-12
Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
Time frame: Weeks 5-12
Number of Units of Red Blood Cells Transfused During Weeks 5-12
Time frame: Weeks 5-12
Number of Days of Red Blood Cell Transfusions During Weeks 5-12
Time frame: Weeks 5-12

Results and safety

Results posted to the registry on 29 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Darbepoetin Alfa 3 μg/kg	228	138
Observation	59	31

Primary outcome: Number of Participants Hospitalized During the Test Period

Time frame: Weeks 1- 12. Number. Unit: Participants

Measure	Darbepoetin Alfa 3 μg/kg n = 215	Observation n = 45
Value	23	6

Population analysed: Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.

Primary outcome: Days of Hospitalization During the Test Period

Time frame: Weeks 1-12. Mean (Standard Deviation). Unit: days

Measure	Darbepoetin Alfa 3 μg/kg n = 212	Observation n = 44
Value	0.5 (2.2)	0.5 (1.7)

Primary outcome: Number of Hospitalizations During the Test Period

Time frame: Weeks 1-12. Mean (Standard Deviation). Unit: hospitalizations

Measure	Darbepoetin Alfa 3 μg/kg n = 215	Observation n = 45
Value	0.1 (0.5)	0.2 (0.4)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose through End of Study or 30 days after last dose, up to 25 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	65 of 226 (28.8%)	99 of 226 (43.8%)	Not reported
Observation Arm Treated	4 of 33 (12.1%)	21 of 33 (63.6%)	Not reported
Observation Arm Not Treated	4 of 26 (15.4%)	6 of 26 (23.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17602062Charu V, Belani CP, Gill AN, Bhatt M, Tomita D, Rossi G, Ben-Jacob A. Efficacy and safety of every-2-week darbepoetin alfa in patients with anemia of cancer: a controlled, randomized, open-label phase II trial. Oncologist. 2007 Jun;12(6):727-37. doi: 10.1634/theoncologist.12-6-727.
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 Anemia of 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Jan 2014. 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?

Yes. Results are posted in the registry (first posted 29 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Hospitalized During the Test Period (time frame: Weeks 1- 12). The study lists 3 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 NCT00989092, 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 29 Jan 2014.