Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan
- Registration Number
- NCT01132625
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AUY922 AUY922 -
- Primary Outcome Measures
Name Time Method establish maximum tolerate dose (safety and tolerability) about 3 years
- Secondary Outcome Measures
Name Time Method Efficacy assessed by RECIST about 4 years Safety assessed by type, frequency and severity of adverse events about 4 years Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922 about 4 years Pharmacokinetic assessed by Cmax, Tmax, AUC about 3 years
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Sunto-gun, Shizuoka, Japan