Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01719380
• Date of registration: 30/10/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
• Scientific title: 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
• Date of first enrolment: November 23, 2012
• Target sample size: 156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01719380
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Norway, Spain, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Drug: LGX818

Drug: Cetuximab

Drug: BYL719

Primary Outcome(s)

Progression free survival [Time Frame: 2.5 years]

Incidence rate of dose-limiting toxicities [Time Frame: 1.5 years]

Secondary Outcome(s)

Plasma concentration [Time Frame: 1.5 years]

Duration of response [Time Frame: 2.5 years]

Overall response rate [Time Frame: 2.5 years]

Overall survival [Time Frame: 3 years]

Baseline molecular status of potential predictive markers of tumor response or resistance [Time Frame: 2.5 years]

Incidence and severity of adverse events [Time Frame: 2.5 years]

Progression free survival [Time Frame: 1.5 years]

Time to response [Time Frame: baseline, 2 years]

Secondary ID(s)

C4221002

CLGX818X2103

2012-002138-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors