Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

Novartis

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: AUY922

Study type

Interventional

Funder types

Industry

Identifiers

NCT01132625

CAUY922A1101

Details and patient eligibility

About

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

Enrollment

37 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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