Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01132625

First received: May 26, 2010

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 26, 2010

Last Updated Date

February 21, 2013

Start Date ^ICMJE

November 2008

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

establish maximum tolerate dose (safety and tolerability) [ Time Frame: about 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

establish maximum tolerate dose (safety and tolerability) [ Time Frame: 2.4 years ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01132625 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety assessed by type, frequency and severity of adverse events [ Time Frame: about 4 years ] [ Designated as safety issue: Yes ]
Efficacy assessed by RECIST [ Time Frame: about 4 years ] [ Designated as safety issue: No ]
Pharmacokinetic assessed by Cmax, Tmax, AUC [ Time Frame: about 3 years ] [ Designated as safety issue: No ]
Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922 [ Time Frame: about 4 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety assessed by type, frequency and severity of adverse events [ Time Frame: 2.4 years ] [ Designated as safety issue: Yes ]
Efficacy assessed by RECIST [ Time Frame: 2.4 years ] [ Designated as safety issue: No ]
Pharmacokinetic assessed by Cmax, Tmax, AUC [ Time Frame: 2.4 years ] [ Designated as safety issue: No ]
Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922 [ Time Frame: 2.4 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Solid Tumors

Intervention ^ICMJE

Drug: AUY922

Study Arm (s)

Experimental: AUY922

Intervention: Drug: AUY922

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01132625

Other Study ID Numbers ^ICMJE

CAUY922A1101

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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