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NCT01719380 · ClinicalTrials.gov registry record · Phase 2
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
NCT01719380: Completed Phase 2 study, sponsored by Pfizer.
NCT01719380 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 156 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01719380, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer
Primary Outcome
DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyper
Interventions
- DRUG Cetuximab
- DRUG BYL719
- DRUG LGX818
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2012-11-23 |
| Est. Completion | 2019-02-12 |
| Phase | Phase 2 |
What the finished NCT01719380 record still lists
NCT01719380 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT01719380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01719380 about?
NCT01719380 is a clinical study titled "Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer". This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer
What is the current status of trial NCT01719380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2012-11-23. Estimated completion is 2019-02-12.
What interventions are being tested in trial NCT01719380?
The interventions under investigation include: Cetuximab (DRUG), BYL719 (DRUG), LGX818 (DRUG).
Who is sponsoring clinical trial NCT01719380?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01719380's enrollment target sits among peer trials
156 445th of 2000 higher than 1,553 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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