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Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

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ClinicalTrials.gov Identifier: NCT01132625
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AUY922 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: AUY922 Drug: AUY922



Primary Outcome Measures :
  1. establish maximum tolerate dose (safety and tolerability) [ Time Frame: about 3 years ]

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


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01132625     History of Changes
Other Study ID Numbers: CAUY922A1101
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

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