Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan
NCT ID: NCT01132625
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2008-11-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AUY922
AUY922
Interventions
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AUY922
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Sunto-gun, Shizuoka, Japan
Countries
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Related Links
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Results for CAUY922A1101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CAUY922A1101
Identifier Type: -
Identifier Source: org_study_id