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A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma

Phase 1
18 Years
Open (Enrolling)
Uveal Melanoma

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Trial Information

A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma

Inclusion Criteria:

- Uveal melanoma with biopsy proven metastatic disease

- Males and females ≥ 18 years of age

- Consent to biopsy of tumor

- Evaluable disease (escalation part only) or measurable disease according to RECIST

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation

Outcome Time Frame:

cycle 1 (28 days)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

February 2014

Related Keywords:

  • Uveal Melanoma
  • Uveal melanoma
  • phase 1
  • AEB071
  • Metastatic
  • Melanoma
  • Uveal Neoplasms



Dana Farber Cancer Institute DFCI - Brookline Boston, Massachusetts  02115
Memorial Sloan Kettering Cancer Center MSKCC 4 New York, New York  10021