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

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.
 
ClinicalTrials.gov Identifier: NCT01719380
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 30, 2012
First Posted Date  ICMJE November 1, 2012
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE November 23, 2012
Actual Primary Completion Date October 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • Incidence rate of dose-limiting toxicities [ Time Frame: 1.5 years ]
    Phase I
  • Progression free survival [ Time Frame: 2.5 years ]
    Phase II
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: LGX818
  • Drug: Cetuximab
  • Drug: BYL719
Study Arms  ICMJE
  • Experimental: LGX818 + cetuximab
    Interventions:
    • Drug: LGX818
    • Drug: Cetuximab
  • Experimental: LGX818 + BYL719 + cetuximab
    Interventions:
    • Drug: LGX818
    • Drug: Cetuximab
    • Drug: BYL719
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
156
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2012)
124
Actual Study Completion Date  ICMJE February 12, 2019
Actual Primary Completion Date October 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01719380
Other Study ID Numbers  ICMJE CLGX818X2103
2012-002138-35 ( EudraCT Number )
C4221002 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2020

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