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: 19 Mar 2018
At a glance
- Drugs Plinabulin (Primary) ; Pegfilgrastim
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Acronyms Protective-1
- 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 3 portion is expected to enroll approximately 150 cancer patients with NSCLC, breast or prostate cancer at 55 sites in the U.S., China, Ukraine, Russia and Hungary. As per protocol of this trial, an interim analysis will be performed after 100 patients have been dosed after first cycle of chemotherapy. Interim data expected in the second half of 2018.
- 19 Mar 2018 According to a BeyondSpring Pharmaceuticals media release, the Company has initiated the Phase 3 portion of this trial. The Study Initiation meeting was held in Dalian, China with the BeyondSpring team, CIN global Principal Investigator Dr. Douglas Blayney and more than 70 clinical investigators and supporting staff.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History