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

Information source: Bio Sidus SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Antineoplastic Chemotherapy Induced Anemia

Intervention: Epoetin alfa (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bio Sidus SA

Official(s) and/or principal investigator(s):
Roberto Diez, MD, Study Director, Affiliation: Bio Sidus SA

Overall contact:
Roberto Diez, MD, Phone: 5411-4909-8049, Email: r.diez@biosidus.com.ar

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events

Secondary outcome:

Hemoglobin levels and percentage of responders

Quality of life

Hemoglobin levels ≥ 2 g/dl

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- Pregnant or lactating

- Patient with known allergy to human albumin or related products

Locations and Contacts

Roberto Diez, MD, Phone: 5411-4909-8049, Email: r.diez@biosidus.com.ar

Centro de Medicina Integral e Investigación Clínica, Buenos Aires, Argentina; Recruiting
Carlos Guzman Machado, MD

Centro Oncologico de Investigaciones Buenos Aires, Berazategui, Buenos Aires, Argentina; Recruiting
Mirta Varela, MD

Hospital Zonal Especializado en Oncología de Lanus, Lanus Este, Buenos Aires CP 1824, Argentina; Recruiting
Eduardo Diez, MD, Phone: 5411-4241-2968, Email: terapeutica.lanus@yahoo.com.ar

Additional Information

Starting date: June 2011
Last updated: December 13, 2012

Page last updated: August 23, 2015

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