AnemiaPhase 1/2NCT00540384
Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
A Phase 1/2 study testing Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) in people with Anemia and Solid Tumors, run by Amgen.
Trial summary
The purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy. Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia, Solid Tumors
- What is being tested?
- Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Jun 2002
- Phase
- Phase 1/2
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with solid tumour(s)
- Anaemia (hgb less than or equal to 11.0 g/dL
- Planned to receive cyclic chemotherapy
- At least 6-month life expectancy
- Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
- Adequate renal and liver function
- At least 18 years of age
Who cannot join
- Central nervous system disease
- Iron deficiency
- Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation
- Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation
- History of any seizure disorder
- Cardiac disease
Show all 12Show fewer
- Active infection or inflammatory disease
- Known positive test for HIV infection
- Known primary haematologic disorder which could cause anaemia
- Use of other investigational agent(s)/device(s)
- Pregnant or breast feeding
- Known hypersensitivity to any recombinant mammalian derived product
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
The purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy.
Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
- Conditions
- Anemia, Solid Tumors
- Being tested
- Placebo, Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
- Keywords
- Anemia, Solid tumors, Multicycle chemotherapy, NESP
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)Drug
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
| Study group | Role | What they receive |
|---|---|---|
| NESP - Schedule 1 Part A | Experimental | Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks Receives: Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) |
| NESP - Schedule 2 Part A | Experimental | NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks Receives: Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) |
| Placebo - Schedule 1 Part A | Placebo comparator | Placebo Q3W for 12 weeks Receives: Drug: Placebo |
| NESP - Schedule 1 Part B | Experimental | Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb < 13.0g/dL and/or RBC transfusion in previous 2 weeks. Receives: Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) |
| Placebo - Schedule 2 Part A | Placebo comparator | Placebo Q4W for 12 weeks Receives: Drug: Placebo |
| NESP - Schedule 2 Part B | Experimental | Open-label NESP at the dose of study drug administered at the end of Part A Receives: Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of adverse events and antibody formation to NESP
Measured: throughout the study
Secondary outcomes (7)
Number and proportion of subjects who receive any RBC transfusion, number of units of RBC transfused, and number of days with at least one RBC transfusion during weeks 1-12, 1-4, 5-8, 9-12, and 5-12, with emphasis on the 5-12 week window
Measured: during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
Selected domains of quality of life (QOL) measured by FACT-G and FACT-anaemia scales, BSI depression and BSI anxiety scales, and de novo questions
Measured: throughout the study
Relationship between these QOL measurements and hgb
Hgb correction to greater than or equal to 12.0 g/dL in the absence of a red blood cell (RBC) transfusion during the preceding 4 weeks during treatment phase
Measured: during treatment phase
Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
Measured: during the treatment phase
Time to hgb response and hgb correction after the initiation of treatment
Measured: after the initiation of treatment
Change in hgb measured at the end of the treatment phase compared to baseline
Measured: baseline to end of the treatment phase
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 startJul 1999
- Primary completionMar 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540384
- Sponsor's protocol ID
- 980291
- Status last verified
- May 2013
- First submitted
- 4 Oct 2007
- Last updated
- 8 May 2013
- Results posted
- No
Publications
Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, Rossi G, Mackey J; Aranesp 980291 Study Group. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer. 2003 Sep;39(14):2026-34. doi: 10.1016/s0959-8049(03)00456-8.
PubMed 12957457
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
- ClinicalTrials.gov ID
- NCT00540384
- Acronym / sponsor ID
- 980291
- Conditions
- Anemia, Solid Tumors
- Keywords
- Anemia, Solid tumors, Multicycle chemotherapy, NESP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Primary completion
- Mar 2002 (actual)
- Study completion
- Jun 2002 (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 assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy.
Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NESP - Schedule 1 Part A | Experimental | Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks |
| NESP - Schedule 2 Part A | Experimental | Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks |
| Placebo - Schedule 1 Part A | Placebo comparator | Drug: PlaceboPlacebo Q3W for 12 weeks |
| NESP - Schedule 1 Part B | Experimental | Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb < 13.0g/dL and/or RBC transfusion in previous 2 weeks. |
| Placebo - Schedule 2 Part A | Placebo comparator | Drug: PlaceboPlacebo Q4W for 12 weeks |
| NESP - Schedule 2 Part B | Experimental | Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)Open-label NESP at the dose of study drug administered at the end of Part A |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject with solid tumour(s)
- Anaemia (hgb less than or equal to 11.0 g/dL
- Planned to receive cyclic chemotherapy
- At least 6-month life expectancy
- Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Key exclusion criteria (12 listed)
- Central nervous system disease
- Iron deficiency
- Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation
- Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation
- History of any seizure disorder
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo - Schedule 1 Part A, Placebo - Schedule 2 Part A |
| Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) | Drug | NESP - Schedule 1 Part A, NESP - Schedule 1 Part B, NESP - Schedule 2 Part A, NESP - Schedule 2 Part B |
Primary outcome
Occurence of adverse events and antibody formation to NESP
Time frame: throughout the study
7 secondary outcomes
Number and proportion of subjects who receive any RBC transfusion, number of units of RBC transfused, and number of days with at least one RBC transfusion during weeks 1-12, 1-4, 5-8, 9-12, and 5-12, with emphasis on the 5-12 week window
Time frame: during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
Selected domains of quality of life (QOL) measured by FACT-G and FACT-anaemia scales, BSI depression and BSI anxiety scales, and de novo questions
Time frame: throughout the study
Relationship between these QOL measurements and hgb
Hgb correction to greater than or equal to 12.0 g/dL in the absence of a red blood cell (RBC) transfusion during the preceding 4 weeks during treatment phase
Time frame: during treatment phase
Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
Time frame: during the treatment phase
Time to hgb response and hgb correction after the initiation of treatment
Time frame: after the initiation of treatment
Change in hgb measured at the end of the treatment phase compared to baseline
Time frame: baseline to end of the treatment phase
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 8 May 2013.
- Results publication: PubMed 12957457Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, Rossi G, Mackey J; Aranesp 980291 Study Group. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer. 2003 Sep;39(14):2026-34. doi: 10.1016/s0959-8049(03)00456-8.
- FDA-approved Drug LabelingLink provided by the sponsor.
- 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 1/2 study testing Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) in people with Anemia and Solid Tumors, 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 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 8 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Occurence of adverse events and antibody formation to NESP (time frame: throughout the study). 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 NCT00540384, 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 8 May 2013.