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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Array BioPharma Identifier:
First received: October 30, 2012
Last updated: March 29, 2017
Last verified: March 2017
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
Intervention Model: Single Group Assignment
Masking: No masking
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 Array BioPharma:

Primary Outcome Measures:
  • Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ]
    Phase I

  • Progression free survival [ Time Frame: 2.5 years ]
    Phase II

Secondary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 2.5 years ]
  • Plasma concentration [ Time Frame: 1.5 years ]
  • Overall response rate [ Time Frame: 2.5 years ]
  • Duration of response [ Time Frame: 2.5 years ]
  • Time to response [ Time Frame: baseline, 2 years ]
  • Progression free survival [ Time Frame: 1.5 years ]
    Phase Ib

  • Overall survival [ Time Frame: 3 years ]
    Phase II

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

Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: March 1, 2018
Estimated Primary Completion Date: July 31, 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 30 Study Locations
Sponsors and Collaborators
Array BioPharma
Study Director: Array BioPharma 303-381-6604
  More Information

Responsible Party: Array BioPharma Identifier: NCT01719380     History of Changes
Other Study ID Numbers: CLGX818X2103
2012-002138-35 ( EudraCT Number )
Study First Received: October 30, 2012
Last Updated: March 29, 2017

Keywords provided by Array BioPharma:
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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents processed this record on April 28, 2017