A Phase II trial of Elacestrant (RAD1901) in patient with advanced breast cancer
Phase of Trial: Phase II
Latest Information Update: 18 Oct 2017
At a glance
- Drugs Elacestrant (Primary)
- Indications Advanced breast cancer
- Focus Registrational; Therapeutic Use
- Sponsors Radius Health Inc.
- 18 Oct 2017 According to a Radius Health media release, expect to enroll the first patient in this study in early 2018.
- 03 Aug 2017 According to a Radius Health media release,the US FDA agreed that a single-arm monotherapy Phase 2 study of under 200 patients is appropriate and provided additional feedback on the proposed clinical protocol, including confirmation that the primary endpoint will be objective response rate ("ORR"), coupled with durability of response ("DOR").
- 03 Aug 2017 According to a Radius Health media release, the US FDA has indicated that, depending on the study results, which must demonstrate superiority to then available therapies, this Phase 2 trial could be considered a pivotal study for accelerated approval as long as the company has commenced a confirmatory study by the time of NDA submission.