A phase Ib/II, open-label, multicenter study of AEB071 and MEK162 in adult patients with metastatic uveal melanoma

ovartis Pharma Services0 个研究点目标入组 125 人开始时间: 2013年7月4日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•- 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 62
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 63

•- 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 retinal vein occlusion (RVO) or current risk factors for RVO
•- 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•- Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment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

发起方

ovartis Pharma Services