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NCT04744831 · ClinicalTrials.gov registry record · Phase 2
Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
NCT04744831: Completed Phase 2 study, sponsored by Daiichi Sankyo.
NCT04744831 is a Phase 2 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 122 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04744831, a Phase 2 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).
Primary Outcome
Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Interventions
- DRUG DS-8201a 5.4 mg/kg Q3W
- DRUG DS-8201a 6.4 mg/kg Q3W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 2 |
What the finished NCT04744831 record still lists
NCT04744831 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which DS-8201a 5.4 mg/kg Q3W is the first listed.
NCT04744831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04744831 about?
NCT04744831 is a clinical study titled "Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer". This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).
What is the current status of trial NCT04744831?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2021-03-05. Estimated completion is 2024-12-04.
What interventions are being tested in trial NCT04744831?
The interventions under investigation include: DS-8201a 5.4 mg/kg Q3W (DRUG), DS-8201a 6.4 mg/kg Q3W (DRUG).
Who is sponsoring clinical trial NCT04744831?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04744831's enrollment target sits among peer trials
122 565th of 2000 higher than 1,434 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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