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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

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: LGX818 Drug: Cetuximab Drug: BYL719 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
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
Actual Study Start Date : November 23, 2012
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: LGX818 + cetuximab Drug: LGX818
Drug: Cetuximab
Experimental: LGX818 + BYL719 + cetuximab Drug: LGX818
Drug: Cetuximab
Drug: BYL719



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

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


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

  7. Overall survival [ Time Frame: 3 years ]
    Phase II

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


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


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01719380    
Other Study ID Numbers: CLGX818X2103
2012-002138-35 ( EudraCT Number )
C4221002 ( Other Identifier: Pfizer )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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
Keywords provided by Pfizer:
Open-label dose escalation; BRAF inhibitor; LGX818; PI3K inhibitor; BYL719; EGFR; cetuximab; metastatic colorectal cancer; KRAS; BRAF; V600
Additional relevant MeSH terms:
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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, Immunological
Antineoplastic Agents