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
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumors
Drug: AUY922
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: November 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AUY922 Drug: AUY922

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132625

Locations
Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Sunto-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01132625     History of Changes
Other Study ID Numbers: CAUY922A1101
Study First Received: May 26, 2010
Last Updated: February 21, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Novartis:
HSP90
molecular chaperone
advanced solid tumors
Japan

ClinicalTrials.gov processed this record on April 17, 2014