A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Antineoplastic Chemotherapy Induced Anemia
- Sponsor
- Bio Sidus SA
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
Time Frame: Baseline to 12 weeks
Secondary Outcomes
- Quality of life(12 Weeks)
- Hemoglobin levels and percentage of responders(Every 4 weeks and 12 weeks)
- Hemoglobin levels ≥ 2 g/dl(12 weeks)