Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Colorectal Cancer	Drug: LGX818 Drug: Cetuximab Drug: BYL719	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
Phase I
Progression free survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Phase II

Secondary Outcome Measures:

Incidence and severity of adverse events [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Plasma concentration [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Overall response rate [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Time to response [ Time Frame: baseline, 2 years ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Phase Ib
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Phase II
Baseline molecular status of potential predictive markers of tumor response or resistance [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	November 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LGX818 + cetuximab	Drug: LGX818 Drug: Cetuximab
Experimental: LGX818 + BYL719 + cetuximab	Drug: LGX818 Drug: Cetuximab Drug: BYL719

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719380

Contacts

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations

United States, California
UCLA/ University of California Los Angeles Dept. of UCLA	Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Vanity Campbell 310-825-4493 vancampbell@mednet.ucla.edu
Principal Investigator: Zev A. Wainberg
USC/Kenneth Norris Comprehensive Cancer Center USC 2	Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Zeno Ashai 323-865-0820 zeno.ashai@med.usc.edu
Principal Investigator: Heinz-Josef Lenz
United States, Massachusetts
Massachusetts General Hospital Mass General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Susan Sheehan, RN 617-724-9347 ssheehan1@partners.org
Principal Investigator: David P. Ryan
United States, Tennessee
Sarah Cannon Research Institute SCRI SC	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Alexandria Duncan 615-329-7432 Alexandria.Duncan@scresearch.net
Principal Investigator: Johanna Bendell
Canada, Ontario
Novartis Investigative Site	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site	Not yet recruiting
Montreal, Quebec, Canada, H2X 3J4
France
Novartis Investigative Site	Not yet recruiting
Montpellier Cedex 5, France, 34298
Novartis Investigative Site	Not yet recruiting
Saint Herblain cedex, France, 44805
Novartis Investigative Site	Not yet recruiting
Toulouse Cedex 3, France, 31052
Germany
Novartis Investigative Site	Not yet recruiting
Essen, Germany, 45147
Netherlands
Novartis Investigative Site	Not yet recruiting
Utrecht, the Netherlands, Netherlands, 3508 GA
Novartis Investigative Site	Recruiting
Amsterdam, Netherlands, 1066 CX
Spain
Novartis Investigative Site	Not yet recruiting
Barcelona, Cataluna, Spain, 08035
Novartis Investigative Site	Not yet recruiting
Madrid, Spain, 28041

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01719380 History of Changes
Other Study ID Numbers:	CLGX818X2103, 2012-002138-35
Study First Received:	October 30, 2012
Last Updated:	January 25, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013