drugset / Trial / NCT03294577
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia
RandomizedParallel-groupTriple-blindSupportive care
Summary
The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + 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
- 2019-10-23
- Primary completion
- 2020-09-25
- Completion
- 2025-09-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |
| Subject | Plinabulin | Small molecule | 40 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Docetaxel | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |