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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Novartis Investigative Site, Kashiwa, Chiba, Japan
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
Primary outcomes
-
establish maximum tolerate dose (safety and tolerability)
Time frame: about 3 years
Secondary outcomes
-
Safety assessed by type, frequency and severity of adverse events
Time frame: about 4 years
-
Efficacy assessed by RECIST
Time frame: about 4 years
-
Pharmacokinetic assessed by Cmax, Tmax, AUC
Time frame: about 3 years
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors
NCT04826341
Advanced Solid Tumors, HRD Cancer
Bethesda, Maryland, United States
View Trial DetailsA Trial of SHR-7367 in Subjects With Advanced Solid Tumors
NCT05740202
Advanced Solid Tumors
Tianjin, Tianjin Municipality, China
View Trial DetailsSafety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
NCT06242691
Advanced Solid Tumors
Louisville, Kentucky, United States
View Trial DetailsA Study of LY3537982 in Chinese Participants With Advanced Solid Tumors
NCT06235983
Advanced Solid Tumors
Changchun, Jilin, China
View Trial Details