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

May 26, 2010
February 21, 2013
November 2008
May 2012   (final data collection date for primary outcome measure)
establish maximum tolerate dose (safety and tolerability) [ Time Frame: about 3 years ] [ Designated as safety issue: Yes ]
establish maximum tolerate dose (safety and tolerability) [ Time Frame: 2.4 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01132625 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: AUY922
Experimental: AUY922
Intervention: Drug: AUY922
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2012
May 2012   (final data collection date for primary outcome measure)

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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01132625
CAUY922A1101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

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