Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

NCT01132625 | Completed Phase 1

• 1 other identifier: CAUY922A1101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumors

Keywords

HSP90; molecular chaperone; advanced solid tumors; Japan

Outcome Measures

Primary Outcomes (1)

• establish maximum tolerate dose (safety and tolerability)

  about 3 years

Secondary Outcomes (4)

• 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

Study Arms (1)

AUY922

EXPERIMENTAL

Drug: AUY922

Interventions

AUY922 DRUG

AUY922

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Related Links

• Results for CAUY922A1101 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Interventions

5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: November 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 9, 2020

Record last verified: 2013-02

Locations

JP (2)