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

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.