Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients

Novartis

Status and phase

Completed

Phase 1

Conditions

Uveal Melanoma

Treatments

Drug: AEB071

Study type

Interventional

Funder types

Industry

Identifiers

NCT01430416

COEB071X2102

2011-002535-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.