Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: AUY922

• 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

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-02
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

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

Novartis Investigative Site

🇯🇵Sunto-gun, Shizuoka, Japan