Clinical trial · Interventional
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer
NCT01719380CI-TRIAL-00052396completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BYL719 | Drug | Alpelisib | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| LGX818 | Drug | Encorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LGX818 + cetuximab
- interventionNames
- Drug: LGX818
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- LGX818 + BYL719 + cetuximab
- interventionNames
- Drug: LGX818
- Drug: Cetuximab
- Drug: BYL719
Primary outcomes (2)
- measure
- Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1
- timeFrame
- Cycle 1: Day 1 to Day 28
- description
- 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: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic colorectal cancer * Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens * Life expectancy ≥ 3 months * ECOG performance status ≤ 2 Exclusion Criteria: * Symptomatic or untreated leptomeningeal disease * Symptomatic brain metastasis * Patients with clinically manifested diabetes * Acute or chronic pancreatitis * Clinically significant cardiac disease Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.