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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00526045 |
Purpose
This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics and pharmacodynamics will be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hematologic Neoplasms |
Drug: AUY922 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation, Multi-center, Open-label Study of AUY922 Administered IV on a Once Weekly Schedule in Adult Patients With Advanced Solid Malignancies Including Phase II Expansion Arms in Patients With Either HER2 Positive or ER Positive Locally Advanced or Metastatic Breast Cancer. |
| Estimated Enrollment: | 125 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AUY922 |
| Experimental: 2 | Drug: AUY922 |
| Experimental: 3 | Drug: AUY922 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Dose-escalation and MTD dose expansion arm: Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists.
Breast cancer phase II expansion arms only:
Females patients with HER2 positive non-operable locally advanced or metastatic breast cancer must have:
HER2 positive patients, tumor/s must demonstrate HER2 over-expression based on either:
Exclusion criteria:
Patients with CNS metastasis which are:
Note: patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
Patient who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
Cardia exclusion criteria:
Mean QTc ≥ 450 msec on screening ECG and clinically significant ECG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or depressions > 1mm, or 2nd (Mobitz II) or 3rd degree AV block; clinically significant ECG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or depressions > 1mm, or 2nd (Mobitz II) or 3rd degree AV block.
History (or family history) of long QT syndrome, heart failure or left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO, history of clinically manifest ischemic heart disease including myocardial infarction, stable or unstable angina, coronary arteriography or cardiac stress testing/imaging with findings consistent with coronary occlusion or infarction, ≤ 6 months prior to study start; history or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, California | |
| David Geffen School of Medicine at UCLA | |
| Los Angeles, California, United States, 90095 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115-6084 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, Texas | |
| University of Texas, MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Cancer Therapy and Research Center @ the UT Hospital Science Center | |
| San Antonio, Texas, United States, 78229 | |
| Netherlands | |
| Novartis Investigative Site | |
| Groningen, Netherlands | |
| Switzerland | |
| Novartis Investigative Site | |
| Bellinzona, Switzerland | |
| United Kingdom | |
| Novartis Investigative site | |
| London, United Kingdom | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00526045 History of Changes |
| Other Study ID Numbers: | CAUY922A2101 |
| Study First Received: | September 5, 2007 |
| Last Updated: | August 8, 2011 |
| Health Authority: | United States: Food and Drug Administration; Switzerland: Federal Office of Public Health; United Kingdom: Department of Health; The Netherlands: Independent Ethics Committee |
|
AUY922 Solid tumors Breast Cancer Phase I/II Advanced Solid malignancies (Phase I) |
Breast Cancer ( Phase II ) HER2+ ER+ HSP90 |
|
Breast Neoplasms Neoplasms Hematologic Neoplasms Neoplasms by Site |
Breast Diseases Skin Diseases Hematologic Diseases |