Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

December 6, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Novartis Investigative Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AUY922
Drug: AUY922

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
establish maximum tolerate dose (safety and tolerability)
Time Frame: about 3 years
about 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by type, frequency and severity of adverse events
Time Frame: about 4 years
about 4 years
Efficacy assessed by RECIST
Time Frame: about 4 years
about 4 years
Pharmacokinetic assessed by Cmax, Tmax, AUC
Time Frame: about 3 years
about 3 years
Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922
Time Frame: about 4 years
about 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUY922A1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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