Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132625
• Other study ID #: CAUY922A1101
• Status: Completed
• Phase: Phase 1
• Start date: November 2008
• Est. completion date: May 2012

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• AUY922

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Sunto-gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish maximum tolerate dose (safety and tolerability)		about 3 years
Secondary	Safety assessed by type, frequency and severity of adverse events		about 4 years
Secondary	Efficacy assessed by RECIST		about 4 years
Secondary	Pharmacokinetic assessed by Cmax, Tmax, AUC		about 3 years
Secondary	Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922		about 4 years

External Links

•   Results for CAUY922A1101 can be found on the Novartis Clinical Trial Results Website