Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01719380
First received: October 30, 2012
Last updated: September 30, 2016
Last verified: September 2016

October 30, 2012
September 30, 2016
November 2012
March 2017   (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.
 
Active, not recruiting
150
Not Provided
March 2017   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Spain
 
NCT01719380
CLGX818X2103, 2012-002138-35
Not Provided
Not Provided
Not Provided
Array BioPharma
Array BioPharma
Not Provided
Study Director: Array BioPharma 303-381-6604
Array BioPharma
September 2016

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