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A Phase lb/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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Phase lb/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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence rate of dose-limiting toxicities

Outcome Description:

Phase I

Outcome Time Frame:

1.5 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLGX818X2103

NCT ID:

NCT01719380

Start Date:

November 2012

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • Open-label dose escalation; BRAF inhibitor; LGX818; PI3K inhibitor; BYL719; EGFR; cetuximab; metastatic colorectal cancer; KRAS; BRAF; V600
  • Colorectal Neoplasms

Name

Location
UCLA/ University of California Los Angeles Dept. of UCLA Los Angeles, California  90095
USC/Kenneth Norris Comprehensive Cancer Center USC 2 Los Angeles, California  90033
Massachusetts General Hospital Mass General Hospital Boston, Massachusetts  02114
Sarah Cannon Research Institute SCRI SC Nashville, Tennessee  37203