Phase 2/3 Neutropenia Prevention with Docetaxel
Phase 2/3 Trial for Solid Tumors in which Docetaxel is Approved
The Phase 2/3 trial of Plinabulin with Docetaxel in patients treated with Docetaxel in all solid tumor indications will evaluate the combination for the prevention of Febrile Neutropenia induced by Docetaxel. The Phase 2 study demonstrated solid efficacy in reducing Neutropenia in patients previously treated with docetaxel and displayed a strong safety profile. These results provided a strong basis to initiate the Phase 2/3 study.
The multi-center, randomized, open label trial plans to enroll approximately 100 patients in each arm for a three-month long study.
The experimental arm consists of combination Plinabulin (20mg/m2) day one combined with Docetaxel (75mg/m2) while the control arm will assess docetaxel along with PEG- G-CSF (75mg/m2).
Planned number of patients for this study is a total of 200 patients for a period of 3 months.
The primary endpoint of the Phase 2/3 trial is the duration of severe neutropenia (DSN; ANC <0.5×109/L) in treatment cycle 1 with secondary endpoints including DSN in cycles 2-3, time to ANC recovery (ANC>3×109/L) in cycles 1-3, incidence of Febrile Neutropenia (ANC < 0.5×109/L and body temperature of 38.5 C) in cycles 1-3, incidence of documented infections cycles 1-3, incidence of adverse events (AEs), incidence and duration of hospitalizations due to Febrile Neutropenia.
Patients treated with Docetaxel in all solid tumor indications.
More information on this pivotal trial, will be available on ClinicalTrial.gov shortly.