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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01132625

Enrollment

Registered

2010-05-28

Start date

2008-11-30

Completion date

2012-05-31

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

HSP90, molecular chaperone, advanced solid tumors, Japan

Brief summary

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

Interventions

DRUGAUY922

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
establish maximum tolerate dose (safety and tolerability)	about 3 years

Secondary

Measure	Time frame
Safety assessed by type, frequency and severity of adverse events	about 4 years
Efficacy assessed by RECIST	about 4 years
Pharmacokinetic assessed by Cmax, Tmax, AUC	about 3 years
Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922	about 4 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026