Trials / Completed
CompletedNCT03384940
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Daiichi Sankyo Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
Detailed description
At study start, only Cohort A is active. If, and when, Cohort B and C become active depends on the assessment of benefit and risk observed in the program. The sponsor will inform the investigators if, and when, Cohort B and C are active.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-8201a | DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration |
Timeline
- Start date
- 2018-02-23
- Primary completion
- 2019-08-09
- Completion
- 2020-11-10
- First posted
- 2017-12-28
- Last updated
- 2021-10-18
- Results posted
- 2021-08-24
Locations
25 sites across 5 countries: United States, Italy, Japan, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03384940. Inclusion in this directory is not an endorsement.