Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

Biosidus

Status and phase: Completed; Phase 4

Conditions: Antineoplastic Chemotherapy Induced Anemia

Treatments: Biological: Epoetin alfa

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01374373

BIOS-012010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Pregnant or lactating
• Patient with known allergy to human albumin or related products

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Open Label

Other group

Description:

One arm open label

Treatment:

Biological: Epoetin alfa