Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
Status: Recruiting
Phase: Phase 1
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01430416
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-474
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital
Overall PI:
Frank Stephen Hodi, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Donald Lawrence, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Suzanne MacRae, 617-632-5906,
smacrae@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
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