A phase Ib/II, multicenter, study of LEE011 in combination with LGX818 in adult patients with BRAF mutant melanoma

Completed

• Conditions: BRAF mutant skin cancer; 10040900

• Registration Number: NL-OMON40426
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

1. Adult with histologically confirmed diagnosis of locally advanced or metastatic melanoma along with written documentation of any BRAF V600 mutation.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
3. Patients must have evidence of evaluable and/or measurable disease, by RECIST v1.1.
4. A representative tumor sample is available for molecular testing
5. A sufficient interval must have elapsed, Cytotoxic chemotherapy >= 2 weeks, biologic therapy >= 4 weeks.
6. A negative serum βHCG test <= 72 hours before starting study treatment for premenopausal women and for women < 1 years after the onset of menopause

Exclusion Criteria

1. Symptomatic brain metastases. Asymptomatic stable metastases are allowed.
2. Symptomatic or untreated leptomeningeal disease.
3. Patients with the abnormal laboratory values during screening, please check protocol for specific info: ANC, Hgb, platelets, serum creatine, serum total bilirubine, ASAT and ALAT
4. Impairment of gastro-intestinal function /GI disease that may significantly alter the absorption
5. In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor
6. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: LVEF <= 45%, QTcF >450 ms for males and >470 ms for females.
7. Patients who are currently receiving treatment QTc prolongators
8. History of thromboembolic or cerebrovascular events within the last 6 months,
9. Patients with concurrent severe and/or uncontrolled concurrent medical conditions
10. Previous or concurrent malignancy.
11. Major surgery < 2 weeks before starting study treatment
12. Patients unwilling or unable to comply with the protocol
13. Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C
14. Pregnant or nursing (lactating) women
15. Women of child-bearing potential, unless highly effective methods of contraception or post-menopausal. Sexually active male must use a condom during intercourse

Study & Design

• Study Type: Interventional
• Study Design: Not specified