Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients

Completed · Phase 1

Conditions studied: Uveal Melanoma

In brief

This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.

Key facts

Study ID

NCT01430416

Run by

Novartis Pharmaceuticals

People needed

153

Starts

2011-12-20

Expected to finish

2019-05-22

Last updated by the study team

2020-12-19

Who can join

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

You may qualify if…

• Uveal melanoma with biopsy proven metastatic disease
• Males and females ≥ 18 years of age
• Consent to biopsy of tumor
• Measurable disease according to RECIST version 1.1
• WHO performance status of ≤ 1

You may not qualify if…

• Patients with abnormal laboratory values as defined by the protocol
• Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
• Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
• Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
• Patients with impairment of gastrointestinal function or disease
• Patients with severe systemic infections
• Patients who are known to be HIV positive and/or have active hepatitis B or C infection
• Time since last therapy for treatment of underlying malignancy:
• Cytotoxic chemotherapy: ≤ duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
• Nitrosurea: ≤ 6 weeks
• Biologic therapy: ≤ 4 weeks
• ≤ 5 x PK half-life of a small molecule therapeutic not otherwise defined above
• Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
• Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
• Patients with primary central nervous system tumors or brain metastases.
• Pregnant or nursing (lactating) women.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Dana Farber Cancer Institute DFCI - Brookline — Boston, Massachusetts, United States
• Memorial Sloan Kettering MSKCC 4 — New York, New York, United States
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Leiden, Netherlands
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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