A Phase 2/3, Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy (Protective 1)
Phase of Trial: Phase II/III
Latest Information Update: 09 Nov 2017
At a glance
- Drugs Plinabulin (Primary) ; Pegfilgrastim
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Acronyms Protective-1
- Sponsors BeyondSpring Pharmaceuticals
- 09 Nov 2017 According to a BeyondSpring Pharmaceuticals media release, data from the phase 2 portion of this trial is expected in December 2017 and interim phase 3 data from this trial is expected by mid-2018.
- 06 Jul 2017 According to a BeyondSpring Pharmaceuticals media release, the company expects reporting Phase 2 efficacy data in the second half of 2017 and Phase 3 interim data in 2018, as well as in submitting a New Drug Application (NDA) in 2019 to the FDA and CFDA.
- 06 Jul 2017 According to a BeyondSpring Pharmaceuticals media release, the China Food and Drug Administration (CFDA) has approved the Company's Clinical Trial Applications (CTAs) to allow the initiation of the phase II/III trial of Plinabulin.