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Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

NCT01777776 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-09-13

Study results available
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Summary

To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.

Conditions

  • Locally Advanced Metastatic BRAF Mutant Melanoma

Interventions

DRUG

LEE011

LEE011 will be administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).

DRUG

LGX818

LGX818 will be administered orally, once daily on a continuous dosing schedule (28-day cycle).

Sponsors & Collaborators

  • Array BioPharma

    lead INDUSTRY

Principal Investigators

  • Array BioPharma · 303-381-6604

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Australia
  • Canada
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01777776 on ClinicalTrials.gov