Overview

This trial is active, not recruiting.

Condition uveal melanoma
Treatment aeb071
Phase phase 1
Sponsor Novartis Pharmaceuticals
Start date December 2011
End date September 2016
Trial size 153 participants
Trial identifier NCT01430416, 2011-002535-25, COEB071X2102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
aeb071

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in September 2016.