NCT01777776

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

A Phase Ib/II, Multicenter, Study of LEE011 in Combination With LGX818 in Adult Patients With BRAF Mutant Melanoma.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Array BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.

Conditions

• Locally Advanced Metastatic BRAF Mutant Melanoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-01-29
• Last updated: 2016-09-13
• Results posted: 2016-09-13

Locations

9 sites across 4 countries: United States, Australia, Canada, Netherlands