Clinical Trial: Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
Brief Summary: 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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: September 6, 2011
Date Started: December 20, 2011
Date Completion: October 15, 2017
Last Updated: May 9, 2017
Last Verified: May 2017
