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

This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01719380
First received: October 30, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes

October 30, 2012
January 25, 2013
November 2012
November 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01719380 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
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

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
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: LGX818
  • Drug: Cetuximab
  • Drug: BYL719
  • Experimental: LGX818 + cetuximab
    Interventions:
    • Drug: LGX818
    • Drug: Cetuximab
  • Experimental: LGX818 + BYL719 + cetuximab
    Interventions:
    • Drug: LGX818
    • Drug: Cetuximab
    • Drug: BYL719
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
December 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Canada,   France,   Germany,   Netherlands,   Spain
 
NCT01719380
CLGX818X2103, 2012-002138-35
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP