Trials / Terminated
TerminatedNCT03248492
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 253 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-8201a | DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as low, medium and high intravenous (IV) doses for Part 1 of the trial. The dose for Part 2 will be determined based on results from Part 1. |
Timeline
- Start date
- 2017-08-25
- Primary completion
- 2019-03-21
- Completion
- 2024-05-06
- First posted
- 2017-08-14
- Last updated
- 2025-06-26
- Results posted
- 2020-02-17
Locations
99 sites across 9 countries: United States, Belgium, Canada, France, Italy, Japan, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03248492. Inclusion in this directory is not an endorsement.