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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
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
Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation
Time frame: cycle 1 (28 days)
Number of participants reporting serious adverse events and adverse events - Dose Expansion
Time frame: Baseline, every 28 days
Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1
Time frame: Baseline, 12 months
Progression free survival and time to progression using RECIST version 1.1
Time frame: Baseline, 12 months
Number of patients reporting serious adverse events and adverse events
Time frame: Baseline, 12 months
AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA
Time frame: First 7 months of treatment period
Gα genotype in tumor specimens
Time frame: Baseline, 28 days
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Novartis Investigative Site
London, United Kingdom