CancerPhase 3NCT00111137
Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
A Phase 3 study testing rHuEPO and Darbepoetin alfa in people with Cancer and Non-Myeloid Malignancies, run by Amgen.
Trial summary
The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Non-Myeloid Malignancies
- What is being tested?
- rHuEPO and Darbepoetin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to 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
- Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
- Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
- Karnofsky performance status of greater than or equal to 50%
- Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL
Who cannot join
- Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
- Hematologic disorder previously associated with anemia
- Active bleeding
- Iron deficiency
- Received erythropoietic therapy within 14 days prior to randomization
- Unstable cardiac disease
Show all 12Show fewer
- Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
- Known positive antibody response to any erythropoietic agent
- Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
- Pregnant or breast feeding
- Red blood cell (RBC) transfusion within 4 weeks of screening
- Known hypersensitivity to any recombinant mammalian-derived product
About this study
Official title: A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy
The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.
- Conditions
- Cancer, Non-Myeloid Malignancies
- Being tested
- rHuEPO, Darbepoetin alfa
- Keywords
- darbepoetin alfa, anemia, Amgen, Chemotherapy
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHuEPODrug
rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
Darbepoetin alfaDrug
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
| 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 hematopoietic response during the comparative treatment period
Measured: during the comparative treatment period
Secondary outcomes (9)
Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)
Measured: during the study
Incidence, if any, of neutralizing antibody formation to study drug
Measured: throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
Measured: baseline to first month of treatment
Time to 2 g/dL increase in hemoglobin during the comparative treatment period
Measured: during the comparative treatment period
Change in FACT-Fatigue scale score over time during the comparative treatment period
Measured: during the comparative treatment period
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study
Measured: throughout study
Slope of change in hemoglobin after the first month of treatment
Measured: baseline to first month of treatment
Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period
Measured: during the comparative treatment period
Changes in hemoglobin during the maintenance period
Measured: during the maintenance period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2005 (estimated)
- Study startFeb 2003
- Primary completionNov 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 CancerStudies 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
- 718 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
- NCT00111137
- Sponsor's protocol ID
- 20020139
- Status last verified
- Feb 2008
- First submitted
- 17 May 2005
- Last updated
- 28 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00111137
- Acronym / sponsor ID
- 20020139
- Conditions
- Cancer, Non-Myeloid Malignancies
- Keywords
- darbepoetin alfa, anemia, Amgen, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 18 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 time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.
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 (4 listed)
- Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
- Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
- Karnofsky performance status of greater than or equal to 50%
- Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL
Key exclusion criteria (12 listed)
- Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
- Hematologic disorder previously associated with anemia
- Active bleeding
- Iron deficiency
- Received erythropoietic therapy within 14 days prior to randomization
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 |
|---|---|---|
| rHuEPOrHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12. | Drug | rHuEPO |
| Darbepoetin alfa4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11. | Drug | Darbepoetin alfa |
Primary outcome
Time to hematopoietic response during the comparative treatment period
Time frame: during the comparative treatment period
9 secondary outcomes
Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)
Time frame: during the study
Incidence, if any, of neutralizing antibody formation to study drug
Time frame: throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
Time frame: baseline to first month of treatment
Time to 2 g/dL increase in hemoglobin during the comparative treatment period
Time frame: during the comparative treatment period
Change in FACT-Fatigue scale score over time during the comparative treatment period
Time frame: during the comparative treatment period
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study
Time frame: throughout study
Slope of change in hemoglobin after the first month of treatment
Time frame: baseline to first month of treatment
Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period
Time frame: during the comparative treatment period
Changes in hemoglobin during the maintenance period
Time frame: during the maintenance period
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 28 Feb 2008.
- 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 3 study testing rHuEPO and Darbepoetin alfa in people with Cancer 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 4 inclusion and 12 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 28 Feb 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 hematopoietic response during the comparative treatment period (time frame: during the comparative 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 28 Feb 2008.