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)

Trial Profile

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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top