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)
Phase of Trial: Phase II/III
Latest Information Update: 19 Mar 2018
At a glance
- Drugs Plinabulin (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Acronyms Protective 2
- Sponsors BeyondSpring Pharmaceuticals
- 19 Mar 2018 Based upon the discussions with the CFDA, the Company believes its registration program for Plinabulin in CIN meets the criteria for accelerated approval based upon clinical efficacy trend data and that the efficacy data from both the interim data of the phase 3 portion of Study 105 and the data from the phase 2 portion of Study 106 expected in 2018, if positive, will be sufficient to file its China NDA for CIN in late 2018 or early 2019.
- 19 Mar 2018 According to a BeyondSpring Pharmaceuticals media release, the Phase 2 portion of this Study is enrolling approximately 60 patients phase 3 portion is expected to enroll approximately 120 patients.
- 30 Nov 2017 According to a BeyondSpring Pharmaceuticals media release, the company expects to submit a New Drug Application (NDA) in 2018 to the FDA and CFDA. Also company expects to open US and European sites within the next several months.