AzTrials
AzTrials

CancerPhase 3NCT00135317

AIM 3: Anemia and Iron Management With Every 3 Week Dosing in Anemic Subjects With Nonmyeloid Malignancies

A Phase 3 study testing darbepoetin alfa in people with Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3 week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
darbepoetin alfa
How many people
Not given
Where
No sites listed yet
Study dates
Nov 2004to not given
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

Inclusion Criteria: - Subjects with non-myeloid malignancy (chronic myeloid leukemia [CML], acute leukemia [acute myelogenous leukemia (AML) and acute lymphocytic leukemia (ALL)], hairy cell leukemia, Burkitt's lymphoma and lymphoblastic lymphoma are specifically excluded) - Planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening) - Hemoglobin concentration less than 11 g/dL within 24 hours before randomization - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Known (documented in medical records) history of seizure disorder (subjects with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and have not been taking anti-seizure medication for the previous 5 years) - Known (documented in medical records) history of thromboembolism - Known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (e.g., sickle cell anemia, thalassemia) - Radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow - Unstable or uncontrolled disease/condition, related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia) - Chronic inflammatory disease that is not stable (e.g., rheumatoid arthritis, Crohn's disease, peptic ulcer, ulcerative disease, etc) - Inadequate renal and/or liver function - Received any red blood cell transfusion within 14 days before randomization or any planned red blood cell transfusion between randomization and study day 1 - Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1 - Known sensitivity to iron administration - Subject of reproductive potential is evidently pregnant (e.g., positive serum HCG test) or is breast feeding - Subject of reproductive potential who is not using adequate contraceptive precautions - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

About this study

Official title: A Randomized Open-Label Study of Darbepoetin Alfa Administered Every Three Weeks With or Without Parenteral Iron in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy

The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3 week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration).

Conditions
Cancer
Being tested
darbepoetin alfa
Keywords
oncology, darbepoetin alfa, Aranesp®, Amgen, Non-myeloid malignancy
Medical subject headings
Neoplasms

What participants receive

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

  • darbepoetin alfaDrug

What is being measured

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

  1. Proportion of subjects achieving a hematopoietic response (hemoglobin [hgb] greater than or equal to 12 g/dL or rise in hgb of greater than 2 g/dL) during the treatment period

Secondary outcomes (9)

  1. Time to hematopoietic response in days

  2. The proportion of subjects with at least one red blood cell (RBC) transfusion from week 5 (day 29) to end of treatment period (EOTP)

  3. Change in hemoglobin from baseline to EOTP

  4. The proportion of subjects achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP

  5. The average hgb after achieving a hgb level greater than or equal to 11.0 g/dL

  6. Patient reported outcomes: Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale score from baseline to EOTP

  7. Change in FACT-G Physical Well-being subscale from baseline to EOTP

  8. Change in FACT-G total score from baseline to EOTP

  9. Change in EuroQoL (EQ-5D) thermometer and ED-5D scores from baseline to EOTP

Timeline

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

  1. First posted26 Aug 2005 (estimated)
  2. Study startNov 2004

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00135317
Sponsor's protocol ID
20040156
Status last verified
May 2013
First submitted
24 Aug 2005
Last updated
23 May 2013
Results posted
No

Publications

  • Bastit L, Vandebroek A, Altintas S, Gaede B, Pinter T, Suto TS, Mossman TW, Smith KE, Vansteenkiste JF. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol. 2008 Apr 1;26(10):1611-8. doi: 10.1200/JCO.2006.10.4620.

    PubMed 18375890

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing darbepoetin alfa in people with 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?

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 23 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 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?

Proportion of subjects achieving a hematopoietic response (hemoglobin [hgb] greater than or equal to 12 g/dL or rise in hgb of greater than 2 g/dL) during the treatment period. 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 NCT00135317, 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 23 May 2013.

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