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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719380
First Posted: November 1, 2012
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Array BioPharma
  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
Intervention Model: Parallel Assignment
Masking: None (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 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
Primary Completion Date: October 31, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719380


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

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01719380     History of Changes
Other Study ID Numbers: CLGX818X2103
2012-002138-35 ( EudraCT Number )
First Submitted: October 30, 2012
First Posted: November 1, 2012
Last Update Posted: July 25, 2017
Last Verified: July 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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents