drugset / Trial / NCT04227990
Plinabulin iv Solution in Prevention of TAC Induced Neutropenia
RandomizedParallel-groupOpen-labelSupportive care
Summary
The primary purpose of this study is to compare the duration of severe neutropenia (DSN) in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + monotheray plinabulin or combination plinabulin/pegfilgrastim Severe neutropenia is an absolute neutrophil count (ANC) \<0.5 × 10\^9/L. Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study.
Timeline
- Start
- 2017-11-27
- Primary completion
- 2018-10-15
- Completion
- 2019-01-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 1.5 mg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Subject | Plinabulin | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 30 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Docetaxel | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |