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NCT02164916 · ClinicalTrials.gov registry record · Phase 2
S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT02164916: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT02164916 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02164916, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without vemurafenib in treating colorectal cancer.
Primary Outcome
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase o
Interventions
- BIOLOGICAL cetuximab
- DRUG irinotecan hydrochloride
- DRUG vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2014-11 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 2 |
What the finished NCT02164916 record still lists
NCT02164916 is an interventional study that assigns participants to a tested intervention. The registered 106 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 (20% lower).
The record links to 0 conditions, and to 3 interventions - of which cetuximab is the first listed.
NCT02164916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02164916 about?
NCT02164916 is a clinical study titled "S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer". This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotec...
What is the current status of trial NCT02164916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2014-11. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT02164916?
The interventions under investigation include: cetuximab (BIOLOGICAL), irinotecan hydrochloride (DRUG), vemurafenib (DRUG).
Who is sponsoring clinical trial NCT02164916?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02164916's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 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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