A Phase 2/3, Multicenter, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in Reducing the Duration of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2)
Not yet recruiting
Phase of Trial: Phase II/III
Latest Information Update: 04 Oct 2017
At a glance
- Drugs Plinabulin (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin
- Indications Solid tumours
- Focus Registrational; Therapeutic Use
- Sponsors BeyondSpring Pharmaceuticals
- 26 Sep 2017 Status changed from planning to not yet recruiting.
- 21 Aug 2017 According to a BeyondSpring Pharmaceuticals media release, the company has received US FDA approval to initiate this trial.
- 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.