GCPGC in Chemotherapy-induced Neutropenia

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2010
This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy. Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.
Epistemonikos ID: 8f57026da72c15053e77942a1c383fd6e34b3138
First added on: May 06, 2024