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NCT03043313 · ClinicalTrials.gov registry record · Phase 2
Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
A Phase 2 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT03043313: Completed Phase 2 study, sponsored by Seagen.
NCT03043313 is a Phase 2 study that has completed, run by Seagen. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03043313, a Phase 2 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
Study Summary
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
Primary Outcome
cORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to less than (\<)1.0 centimeter (cm). PR was defined as at least a 30 percentage (%) decrease in post-baseline sum of the diameters (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as re
Interventions
- DRUG Trastuzumab
- DRUG Tucatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2023-11-02 |
| Phase | Phase 2 |
What the finished NCT03043313 record still lists
NCT03043313 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT03043313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03043313 about?
NCT03043313 is a clinical study titled "Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer". This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of th...
What is the current status of trial NCT03043313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2017-06-23. Estimated completion is 2023-11-02.
What interventions are being tested in trial NCT03043313?
The interventions under investigation include: Trastuzumab (DRUG), Tucatinib (DRUG).
Who is sponsoring clinical trial NCT03043313?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03043313's enrollment target sits among peer trials
117 623rd of 2000 higher than 1,378 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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