Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

A Japanese Phase I, Multi-center, Open-label, Study of AUY922 Administered Intravenously on a Once Weekly Schedule in Adult Patients With Advanced Solid Malignancies

This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.

Inclusion Criteria:

• Patients with advanced malignant solid tumors
• ECOG Performance Status of ≤ 2
• Patients must have the following laboratory values:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 8.5 g/dl, Platelets (plt) ≥ 100 x 109/L
• Potassium, Calcium, Magnesium, Phosphorus within normal limits or correctable with supplements
• AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN)
• Serum bilirubin ≤ 1.5 x ULN, Serum albumin > 2.5g/dl, Serum creatinine≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min
• Able to sign informed consent and to comply with the protocol

Exclusion Criteria:

• Patients with brain metastasis.
• Prior treatment with any HSP90 or HDAC inhibitor compound.
• Treatment with therapeutic doses of coumarin anticoagulants.
• Pregnant and lactating women.
• Severe and/or uncontrolled acute or chronic liver disease
• Severe and/or uncontrolled acute or chronic renal disease
• Chronically significant heart disease
• History (or family history) of long QT syndrome. QTc ≥ 450 msec on screening ECG, ischemic heart disease, heart fail, ECG abnormalities, atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
• Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes
• Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g Gilbert's syndrome).

Other protocol-defined inclusion/exclusion criteria may apply