AnemiaPhase 2NCT00327535
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
A Phase 2 study testing Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 68 sites in 15 countries.
Trial summary
This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. 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 and methoxy polyethylene glycol-epoetin beta [Mircera]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 68 sitesin 15 countries
- Study dates
- May 2006to May 2007
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years of age;
- stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
- myelosuppressive chemotherapy scheduled for at least 9 weeks;
- anemia at screening visit.
Who cannot join
- transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
- iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
- prior treatment with Mircera.
Trial locations and contacts
68 sites in 15 countries.
68 sites in 15 countries
France8 sites
Study site
Bobigny, 93009
Study site
Caen, 14076
Study site
Dijon, 21079
Study site
Lyon, 69437
Study site
Paris, 75571
Study site
Pessac, 33600
Study site
Pierre-Bénite, 69495
Study site
Saint-Pierre, 97448
Spain8 sites
Study site
Barcelona, 08003
Study site
Barcelona, 08036
Study site
Girona, 17007
Study site
Madrid, 28034
Study site
Madrid, 28041
Study site
Madrid, 28046
Study site
San Cristóbal de La Laguna, 38320
Study site
Zaragoza, 50009
Italy7 sites
Study site
Genova, 16132
Study site
Legnago, 37045
Study site
Novara, 28100
Study site
Pavia, 27100
Study site
Ravenna, 48100
Study site
San Giovanni Rotondo, 71013
Study site
Sassari, 07100
Poland7 sites
Study site
Bydgoszcz, 85-326
Study site
Elblag, 82-300
Study site
Otwock, 05-400
Study site
Poznan, 60-569
Study site
Radom, 26-617
Study site
Włocławek, 87-800
Study site
Wroclaw, 53-439
Germany6 sites
Study site
Gauting, 82131
Study site
Hamburg, 21075
Study site
Hamburg, 22045
Study site
Heidelberg, 69126
Study site
Karlsruhe, 76137
Study site
Trier, 54290
Austria5 sites
Study site
Linz, 4020
Study site
Salzburg, 5020
Study site
Vienna, 1090
Study site
Vienna, 1145
Study site
Vienna, 1160
Greece5 sites
Study site
Athens, 11527
Study site
Heraklion, 71110
Study site
Larissa, 41 110
Study site
Thessaloniki, 56429
Study site
Thessaloniki, 57001
Hungary5 sites
Study site
Budapest, 1529
Study site
Deszk, 6772
Study site
Mátraháza, 3233
Study site
Nyíregyháza, 4400
Study site
Székesfehérvár, 8001
Czechia4 sites
Study site
Brno, 639 00
Study site
Hradec Králové, 500 05
Study site
Ostrava, 708 52
Study site
Prague, 180 01
Australia3 sites
Study site
East Bentleigh, VIC 3165
Study site
Kurralta Park, 5037
Study site
Milton, 4064
Belgium3 sites
Study site
Aalst, 9300
Study site
Edegem, 2650
Study site
Liège, 4000
Canada2 sites
Study site
Toronto, Ontario, M4C 3E7
Study site
Toronto, Ontario, M5G 2M9
About this study
Official title: A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy
This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- Darbepoetin alfa, methoxy polyethylene glycol-epoetin beta [Mircera]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
6.3 micrograms/kg every 3 weeks
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
9 micrograms/kg every 3 weeks
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
12 micrograms/kg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mircera 6.3 micrograms/kg | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Mircera 9 micrograms/kg | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Mircera 12 micrograms/kg | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Darbepoetin alfa | Active comparator | Not described Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Hb change from baseline
Measured: Weeks 5-13
Secondary outcomes (3)
Target Hb therapeutic range, average Hb values, hematopoietic response.
Measured: Days 2-85
Red blood cell (RBC) transfusions
Measured: Weeks 5-13
Adverse events (AEs), laboratory parameters, premature withdrawals
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2007
- Study completionMay 2007
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 Hoffmann-La RocheThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327535
- Sponsor's protocol ID
- NH19960
- Status last verified
- Aug 2016
- First submitted
- 16 May 2006
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT00327535
- Acronym / sponsor ID
- NH19960
- Conditions
- Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 18 May 2006 (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.
This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mircera 6.3 micrograms/kg | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Mircera 9 micrograms/kg | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Mircera 12 micrograms/kg | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Darbepoetin alfa | Active comparator | 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)
- >=18 years of age;
- stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
- myelosuppressive chemotherapy scheduled for at least 9 weeks;
- anemia at screening visit.
Key exclusion criteria (3 listed)
- transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
- iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
- prior treatment with Mircera.
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 alfaAccording to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week) | Drug | Darbepoetin alfa |
| methoxy polyethylene glycol-epoetin beta [Mircera]6.3 micrograms/kg every 3 weeks | Drug | Mircera 6.3 micrograms/kg |
| methoxy polyethylene glycol-epoetin beta [Mircera]9 micrograms/kg every 3 weeks | Drug | Mircera 9 micrograms/kg |
| methoxy polyethylene glycol-epoetin beta [Mircera]12 micrograms/kg every 3 weeks | Drug | Mircera 12 micrograms/kg |
Primary outcome
Average Hb change from baseline
Time frame: Weeks 5-13
3 secondary outcomes
Target Hb therapeutic range, average Hb values, hematopoietic response.
Time frame: Days 2-85
Red blood cell (RBC) transfusions
Time frame: Weeks 5-13
Adverse events (AEs), laboratory parameters, premature withdrawals
Time frame: Throughout study
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 11 Aug 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
68 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 68 sites in 15 countries.
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 3 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in France, Spain, Italy, Poland, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Average Hb change from baseline (time frame: Weeks 5-13). 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 11 Aug 2016.