AnemiaPhase 3NCT03776032
A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy
A Phase 3 study testing Darbepoetin alfa in people with Anemia, run by Amgen.
Trial summary
The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 1999to 27 Feb 2002
- 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
- Lung cancer (either small cell [SCLC] or non-small cell [NSCLC])
- At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
- Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
- Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
- Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range)
- Available for 4 weeks post administration of the last dose of study drug
- Legal age for informed consent, and written informed consent must be obtained
Who cannot join
- History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
- Received prior whole pelvis radiation therapy
- Uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%)], or uncontrolled cardiac arrhythmia.
- History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
- Uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg)
- History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years
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- Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis)
- Iron deficiency (transferrin saturation < 15% and ferritin < 10 μg/L (< 10 ng/mL))
- Received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
- Received erythropoietin therapy within 8 weeks before randomization
- Known positive test for human immunodeficiency virus (HIV) infection
- Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication.
- Pregnant or breast feeding females.
- Not using adequate contraceptive precautions
- Prior treatment with NESP
- Previously randomized in this study
- Known hypersensitivity to mammalian-derived product
- Concerns for subject's compliance with the protocol procedure, including completion of the quality of life surveys (QOLS)
About this study
Official title: A Double-Blind, Placebo Controlled, Randomised Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Lung Cancer Subjects Receiving Multicycle Platinum-Containing Chemotherapy
The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.
- Conditions
- Anemia
- Being tested
- Darbepoetin alfa, Placebo
- Keywords
- Lung cancer
- Medical subject headings
- Anemia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Novel Erythropoiesis Stimulating Protein (NESP), Aranesp
Administered by subcutaneous injection once a week
PlaceboDrug
Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa | Experimental | Participants received once a week darbepoetin alfa, administered by subcutaneous injection at a starting dose of 2.25 µg/kg for up to 12 weeks. The dose of darbepoetin alfa may have been adjusted based on hemoglobin levels to a maximum dose of 4.5 µg/kg /week. Receives: Drug: Darbepoetin alfa |
| Placebo | Placebo comparator | Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
Measured: Weeks 5 to 12
Secondary outcomes (15)
Time to First Red Blood Cell Transfusion During Weeks 5 to 12
The number of days from the first day of study week 5 (day 29) to the first administration of a RBC transfusion during the Treatment Phase that occurs on or after day 29.
Measured: Week 5 to week 12
Percentage of Participants with a Hemoglobin Response by Week 12
Hemoglobin Response was defined as an increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin in the absence of any RBC transfusions during the preceding 28 days.
Measured: 12 weeks
Time to Hemoglobin Response
The number of days from the first administration of study drug to the first occurrence of a hemoglobin response.
Measured: 12 weeks
Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
Sustained hemoglobin response was defined as in increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin sustained for at least 28 days or until the end of the Treatment Phase. This increase must have occurred in the absence of RBC transfusions during the period of sustained response and the preceding 28 days.
Measured: 12 weeks
Time to Sustained Hemoglobin Response
The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin response.
Measured: 12 weeks
Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
Hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that occurred in the absence of RBC transfusions during the preceding 28 days.
Measured: 12 weeks
Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
Sustained hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that was sustained for at least 28 days or until the end of the Treatment Phase. This must have occurred in the absence of RBC transfusions during the period of sustained correction and the preceding 28 days.
Measured: 12 weeks
Time to Hemoglobin Correction
The number of days from the first administration of study drug to the first occurrence of a hemoglobin correction.
Measured: 12 weeks
Time to Sustained Hemoglobin Correction
The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin correction.
Measured: 12 weeks
Change from Baseline in Hemoglobin at Week 12
Measured: Baseline and week 12
Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12
Measured: Weeks 1 to 4, 5 to 8, and 9 to 12
Number of Standard Units of RBCs Transfused During Weeks 5 to 12
Measured: Weeks 5 to 12
Number of Days with RBC Transfusions During Weeks 5 to 12
Measured: Weeks 5 to 12
Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12
The FACT-anemia is a 47-item questionnaire to assess specific quality of life concerns related to anemia and fatigue in cancer patients.
Measured: Baseline and week 12
Number of Participants with Adverse Events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start14 Sep 1999
- Primary completion8 Nov 2000
- Study completion27 Feb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776032
- Sponsor's protocol ID
- 00980297
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled, Randomised Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Lung Cancer Subjects Receiving Multicycle Platinum-Containing Chemotherapy
- ClinicalTrials.gov ID
- NCT03776032
- Acronym / sponsor ID
- 00980297
- Conditions
- Anemia
- Keywords
- Lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 1999 (actual)
- Primary completion
- 8 Nov 2000 (actual)
- Study completion
- 27 Feb 2002 (actual)
- First posted
- 14 Dec 2018 (actual)
- 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 primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa | Experimental | Drug: Darbepoetin alfaParticipants received once a week darbepoetin alfa, administered by subcutaneous injection at a starting dose of 2.25 µg/kg for up to 12 weeks. The dose of darbepoetin alfa may have been adjusted based on hemoglobin levels to a maximum dose of 4.5 µg/kg /week. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received once a week placebo, administered by subcutaneous injection for up to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Lung cancer (either small cell [SCLC] or non-small cell [NSCLC])
- At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
- Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
- Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
Key exclusion criteria (18 listed)
- History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
- Received prior whole pelvis radiation therapy
- Uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%)], or uncontrolled cardiac arrhythmia.
- History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
- Uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg)
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: Novel Erythropoiesis Stimulating Protein (NESP), AranespAdministered by subcutaneous injection once a week | Drug | Darbepoetin alfa |
| PlaceboPlacebo matching to darbopoetin alfa administered by subcutaneous injection once a week. | Drug | Placebo |
Primary outcome
Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
Time frame: Weeks 5 to 12
15 secondary outcomes
Time to First Red Blood Cell Transfusion During Weeks 5 to 12
Time frame: Week 5 to week 12
Percentage of Participants with a Hemoglobin Response by Week 12
Time frame: 12 weeks
Time to Hemoglobin Response
Time frame: 12 weeks
Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
Time frame: 12 weeks
Time to Sustained Hemoglobin Response
Time frame: 12 weeks
Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
Time frame: 12 weeks
Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
Time frame: 12 weeks
Time to Hemoglobin Correction
Time frame: 12 weeks
Time to Sustained Hemoglobin Correction
Time frame: 12 weeks
Change from Baseline in Hemoglobin at Week 12
Time frame: Baseline and week 12
Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12
Time frame: Weeks 1 to 4, 5 to 8, and 9 to 12
Number of Standard Units of RBCs Transfused During Weeks 5 to 12
Time frame: Weeks 5 to 12
Number of Days with RBC Transfusions During Weeks 5 to 12
Time frame: Weeks 5 to 12
Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12
Time frame: Baseline and week 12
Number of Participants with Adverse Events
Time frame: 16 weeks
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 20 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin alfa in people with Anemia, 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 8 inclusion and 18 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 20 Dec 2018. 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 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?
Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12 (time frame: Weeks 5 to 12). 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 20 Dec 2018.