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

Stopped early · Phase 1/Phase 2

Conditions studied: Locally Advanced Metastatic BRAF Mutant Melanoma

In brief

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

Key facts

Study ID

NCT01777776

Run by

Array BioPharma

People needed

28

Starts

2013-07-01

Expected to finish

2015-04-01

Last updated by the study team

2016-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years.
• Diagnosis of locally advanced or metastatic melanoma along with written documentation of BRAF V600 mutation.
• ECOG performance status of 0 - 2.
• Patients enrolled into Phase Ib must have evidence of evaluable and/or measurable disease as determined by RECIST v1.1.
• Patients enrolled into Phase II (BRAFi naïve and resistant) must have evidence of measurable disease as determined by RECIST v1.1.
• Archival tumor tissue must be obtained for patients enrolled in Phase Ib and Phase II arm 1a/b- BRAFi naïve patients. If an archival tumor tissue is not available, a fresh tumor sample is acceptable.
• For patients enrolled in the phase II arm 2, patients must agree to undergo a fresh tumor biopsy unless one was collected prior to study entry but at the time of disease relapse from the most recent BRAFi treatment.

You may not qualify if…

• Symptomatic brain metastases.
• Symptomatic or untreated leptomeningeal disease.
• Patients with inadequate laboratory values during screening.
• In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor (e.g., PD 0332991)
• Impaired cardiac function or clinically significant cardiac diseases.
• Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of LEE011 or LGX818.
• Patients with concurrent severe and/or uncontrolled concurrent medical conditions.
• Previous or concurrent malignancy.
• Major surgery < 2 weeks before starting study treatment
• Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• University of Colorado Dept of Oncology — Aurora, Colorado, United States
• Karmanos Cancer Institute Dept of Oncology — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center Dept Oncology — New York, New York, United States
• Oregon Health & Science University Dept. of OHSU (3) — Portland, Oregon, United States
• Vanderbilt University Medical Center SC - Dept of Oncology . — Nashville, Tennessee, United States
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Woodville, South Australia, Australia
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Utrecht, Netherlands, Netherlands

Full record on ClinicalTrials.gov

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