Upstate Active Clinical Trials

Study Title:

Amgen protocol Number: 20070782- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 ug Once Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

What is the purpose of the study?

This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 μg every 3 weeks , Group B: placebo Q3W)

Upstate Institutional Review Board (IRB) Number:

406721

Study/Protocol ID:

Amgen protocol Number: 20070782

Patient Age Group:

Adult

Principal Investigator:

Bernard J Poiesz, MD

ClinicalTrials.Gov ID:

NCT00858364

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Patricia M Benz
Phone: 315-464-8253
Email: benzp@upstate.edu

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