Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Encorafenib in combination with binimetinib have been approved in USA, Europe, Australia, Japan and Switzerland for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation.

The main objective of this study is to find a safe and effective dose of encorafenib in combination with binimetinib for patients who have BRAF-mutant metastatic or unresectable melanoma with hepatic dysfunction (i.e. moderate or severe impairment).

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

Details

• Lead Sponsor: Pierre Fabre Medicament

Criteria

Inclusion Criteria:

1. Histologically/cytologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma

2. Presence of BRAF V600E or V600K mutation

3. ECOG PS of 0 or 1

4. Adequate bone marrow, organ function and laboratory parameters

5. Hepatic function criteria:

• Group with normal hepatic function

• Group with moderate hepatic impairment (Child-Pugh Class B)

• Group with severe impairment (Child-Pugh Class C)

Exclusion Criteria:

1. A calculated Child-Pugh score that showed impairment for a reason other than liver dysfunction (e.g., cancer cachexia)

2. History or symptoms of encephalopathy (Grade II or worse)

3. Clinical evidence of severe ascites

4. History of surgical portosystemic shunt with complications

5. Active bleeding during the last 28 days prior to the first dose of study treatment

6. Anticoagulant therapy