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A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Uveal Melanoma

Thank you

Trial Information

A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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of CYP3A4/5 and cannot be withdrawn prior to study treatment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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: dose limiting toxicity (DLT)

Outcome Description:

A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071and MEK162.

Outcome Time Frame:

Up to 28 days of treatment with AEB071 and MEK162

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


European Union: European Medicines Agency

Study ID:




Start Date:

July 2013

Completion Date:

March 2015

Related Keywords:

  • Uveal Melanoma
  • Melanoma,
  • melanoma of the eye,
  • uveal,
  • MEK162,
  • AEB071
  • Melanoma
  • Uveal Neoplasms



Dana Farber Cancer Institute Dept. Onc Boston, Massachusetts  02115
Memorial Sloan Kettering Cancer Center Dept of Onc.. New York, New York  10021