Description:
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
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
Completed
Phase 2
NCT ID: NCT01719380
ORG ID: CLGX818X2103
NCI ID: 2012-002138-35
Colorectal Cancer
Drug | Synonyms | Arms |
---|---|---|
LGX818 | LGX818 + cetuximab, LGX818 + BYL719 + cetuximab | |
Cetuximab | LGX818 + cetuximab, LGX818 + BYL719 + cetuximab | |
BYL719 | LGX818 + BYL719 + cetuximab |
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
Name | Type | Description | Interventions |
---|---|---|---|
LGX818 + cetuximab | Experimental | LGX818, Cetuximab | |
LGX818 + BYL719 + cetuximab | Experimental | LGX818, Cetuximab, BYL719 |
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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Incidence rate of dose-limiting toxicities
Progression free survival
Incidence and severity of adverse events
Plasma concentration
Overall response rate
Duration of response
Time to response
Progression free survival
Overall survival
Baseline molecular status of potential predictive markers of tumor response or resistance
Open-label dose escalation; BRAF inhibitor; LGX818; PI3K inhibitor; BYL719; EGFR; cetuximab; metastatic colorectal cancer; KRAS; BRAF; V600