drugset / Trial / NCT04345900

Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2

NCT04345900

Phase 2 Completed 55 enrolled BeyondSpring Pharmaceuticals Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications