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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


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

establish maximum tolerate dose (safety and tolerability)

Outcome Time Frame:

about 3 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Study ID:

CAUY922A1101

NCT ID:

NCT01132625

Start Date:

November 2008

Completion Date:

May 2012

Related Keywords:

  • Advanced Solid Tumors
  • HSP90
  • molecular chaperone
  • advanced solid tumors
  • Japan

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