A phase Ib/II, open-label, multicenter study of AEB071 and MEK162 in adult patients with metastatic uveal melanoma
- Conditions
- veal MelanomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000281-11-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
- Written informed consent
- Male and female patients aged 18 years or older
- A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease
- Consent to providing 3 tumor biopsy samples throughout the course of the study
- Presence of measurable disease
- A WHO performance status of less than or equal to 1
Other inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
- Presence of CNS lesions (stable lesions may be acceptable)
- Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years
- Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2
- History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or any predisposing factor to CSR/RVO
- History of retinal degenerative disease
- Impaired cardiac function or clinically significant cardiac disease
- Impaired GI function or disease that could interfere with the absorption of AEB071 and/or MEK162
- Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment
- Females of child-bearing potential who are unwilling or unable to use highly effective means of contraception
- Males who are unwilling or unable to use a condom during sexual intercourse
- Prior exposure to a MEK or PKC inhibitor
Other inclusion/exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method