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Completed

NCT Number: NCT01132625

Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUY922

Drug

Primary outcomes

  1. establish maximum tolerate dose (safety and tolerability)

    Time frame: about 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 28, 2010
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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