Antineoplastic Chemotherapy Induced AnemiaPhase 4NCT01374373
Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
A Phase 4 study testing Epoetin alfa in people with Antineoplastic Chemotherapy Induced Anemia, run by Bio Sidus SA at 3 sites in Argentina.
Trial summary
The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antineoplastic Chemotherapy Induced Anemia
- What is being tested?
- Epoetin alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesArgentina
- Study dates
- Jun 2011to Nov 2014
- Phase
- Phase 4
- 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
- Confirmed diagnosis of non curable cancer or lymphoma
- Receiving a palliative chemotherapy regimen
- Hemoglobin < 10.0 g/dL
- Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status
- Life expectancy of ≥ 3 months
- Postmenopausal o premenopausal women receiving effective contraceptive method
Who cannot join
- Active bleeding that may have caused anemia in the prior 30 days.
- Uncontrolled hypertension
- Anemia for another cause other than cancer or chemotherapy
- Untreated iron or folic acid deficiency
- Transfusion in the last 30 days prior to baseline visit
- Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit
Show all 12Show fewer
- Increased risk of thromboembolic disease
- Radiotherapy in pelvis or spine in the last 60 days
- Myelodysplasic syndrome
- History of congestive heart failure
- Pregnant or lactating
- Patient with known allergy to human albumin or related products
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Centro Oncologico de Investigaciones Buenos Aires
Berazategui, Buenos Aires
Centro de Medicina Integral e Investigación Clínica
Buenos Aires, Buenos Aires
Hospital Zonal Especializado en Oncología de Lanus
Lanús Este, Buenos Aires, CP 1824
About this study
Official title: A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.
Read the detailed description
Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.
- Being tested
- Epoetin alfa
- Keywords
- Chemotherapy, Anemia, Epoetin alfa, Erythropoiesis stimulating agent (ESA)
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfaBiological
Epoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Other | One arm open label Receives: Biological: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Hemoglobin levels and percentage of responders
Evaluate efficacy assessing hemoglobin levels and percentage of responders (increments of Hemoglobin ≥ 1g/dl without transfusion requirements) comparing baseline with final 12 week and intermediate 4 week visits
Measured: Every 4 weeks and 12 weeks
Quality of life
Evaluate if treatment impacts quality of life assessed through the Brief Fatigue Index (BFI) score comparing baseline with final 12 week visit
Measured: 12 Weeks
Hemoglobin levels ≥ 2 g/dl
Evaluate proportion of patient that achieve hemoglobin levels ≥ 2 g/dl without transfusion requirements and the number of patients that require at least one transfusion after 12 weeks of therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineoplastic Chemotherapy Induced AnemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Sidus SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IC RESEARCH GROUP
- Responsible party
- Sponsor
- Investigators
- Roberto Diez, MD, Study director, Bio Sidus SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374373
- Sponsor's protocol ID
- BIOS-012010
- Status last verified
- Apr 2016
- First submitted
- 13 Jun 2011
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01374373
- Acronym / sponsor ID
- BIOS-012010
- Keywords
- Chemotherapy, Anemia, Epoetin alfa, Erythropoiesis stimulating agent (ESA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bio Sidus SAIndustry (pharma, biotech, devices)
- Collaborators
- IC RESEARCH GROUP
- Study start
- Jun 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Jun 2011 (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 safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.
Detailed description
Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Other | Biological: Epoetin alfaOne arm open label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of non curable cancer or lymphoma
- Receiving a palliative chemotherapy regimen
- Hemoglobin < 10.0 g/dL
- Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status
- Life expectancy of ≥ 3 months
Key exclusion criteria (12 listed)
- Active bleeding that may have caused anemia in the prior 30 days.
- Uncontrolled hypertension
- Anemia for another cause other than cancer or chemotherapy
- Untreated iron or folic acid deficiency
- Transfusion in the last 30 days prior to baseline visit
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 |
|---|---|---|
| Epoetin alfaEpoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD | Biological | Open Label |
Primary outcome
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
Time frame: Baseline to 12 weeks
3 secondary outcomes
Hemoglobin levels and percentage of responders
Time frame: Every 4 weeks and 12 weeks
Quality of life
Time frame: 12 Weeks
Hemoglobin levels ≥ 2 g/dl
Time frame: 12 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 7 Apr 2016.
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.
Roberto Diez, MD study director
Bio Sidus SA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alfa in people with Antineoplastic Chemotherapy Induced Anemia, run by Bio Sidus SA at 3 sites in Argentina.
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 6 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events (time frame: Baseline to 12 weeks). 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 7 Apr 2016.