Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
Basic Trial Information
|Phase IV||Supportive care||Active||18 and over||Pharmaceutical / Industry||BIOS-012010|
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.
Further Study Information
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.
- 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
- 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
- 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 Contact Information
Trial Lead Organizations/Sponsors
Bio Sidus SA
- IC RESEARCH GROUP
Centro de Medicina Integral e Investigación Clínica
Carlos Guzman Machado, MD
Centro Oncologico de Investigaciones Buenos Aires
Mirta Varela, MD
Hospital Zonal Especializado en Oncologia de Lanus
Eduardo Diez, MD
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01374373
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.