drugset / Trial / NCT04345900
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
RandomizedParallel-groupOpen-labelTreatment
Summary
To assess the duration of severe neutropenia (DSN) in treatment Cycle 1 in patients treated with docetaxel (75 mg/m2) + plinabulin (5, 10, or 20 mg/m2) or with docetaxel (75 mg/m2) + pegfilgrastim (6 mg). Neutrophils count was to be assessed at baseline (prior to Cycle 1 docetaxel dose) and during Cycle 1 on Days 1, 2, 6, 7, 8, 9, 10, and 15 (pre-dose on dosing days; times equivalent to pre dose on other days).
Timeline
- Start
- 2017-04-05
- Primary completion
- 2018-03-20
- Completion
- 2018-04-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |
| Subject | Plinabulin | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 20 mg/m2 | Intravenous |