A Phase IIa, Open Label, Controlled, Dose Ranging Study of Maxy-G34 as an Adjunct to TAC Chemotherapy in High-Risk Patients With Stage I, II, or IIIa Breast Cancer.
Key
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1.
over 1 cycle of TAC chemotherapy (approximately 3 weeks)
Yes
Santosh Vetticaden, MD
Study Director
Maxygen, Inc.
United States: Food and Drug Administration
MP-CL-30166
NCT00501332
July 2007
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