Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors
Phase of Trial: Phase I
Latest Information Update: 27 Mar 2018
At a glance
- Drugs Trastuzumab-deruxtecan (Primary)
- Indications Adenocarcinoma; Advanced breast cancer; Gastric cancer; Oesophageal cancer; Solid tumours
- Focus Adverse reactions; First in man; Therapeutic Use
- Sponsors Daiichi Sankyo Company
- 27 Mar 2018 According to a Daiichi Sankyo company media release, DS-8201 has received SAKIGAKE Designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).
- 01 Mar 2018 Planned End Date changed from 1 Mar 2018 to 1 Sep 2019.
- 01 Mar 2018 Planned primary completion date changed from 1 Dec 2017 to 1 Dec 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History