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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 30, 2012
Last updated: January 10, 2015
Last verified: January 2015

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:

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: 150
Study Start Date: November 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01719380

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

  Show 33 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01719380     History of Changes
Other Study ID Numbers: CLGX818X2103, 2012-002138-35
Study First Received: October 30, 2012
Last Updated: January 10, 2015
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 26, 2015