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
- 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
- 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
- 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
- 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
Other protocol-defined inclusion/exclusion criteria may apply