BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
NCT ID: NCT01290406
Last Updated: 2012-06-21
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-03-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BEZ235
BEZ235
Interventions
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BEZ235
Eligibility Criteria
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Inclusion Criteria
* Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
* Objective and radiologically confirmed progression of disease after prior first-line treatment
* Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
* At least one measurable lesion as per RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion Criteria
* More than one line of prior treatment for advanced or metastatic disease
* Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
* Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
* Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study
* Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) \< 50%, Q-T interval corrected for heart rate (QTcF) \> 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
* Inadequately controlled hypertension
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
* Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists
* Pregnant or nursing (lactating) woman
18 Years
FEMALE
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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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
City of Hope Medical center
Duarte, California, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Morriswon Memorial Hospital
Morristown, New Jersey, United States
Carolinas Healthcare Systems
Charlotte, North Carolina, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
GHS
Danville, Pennsylvania, United States
Sarah Gautam Rau
Nashville, Tennessee, United States
Texas Oncology, P.A.
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
STOH
San Antonio, Texas, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Novartis Investigative Site
Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Hamilton, , Canada
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Montreal, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Bordeaux, , France
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Caen, , France
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La Roche-sur-Yon, , France
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Le Mans, , France
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Lyon, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Saint-Brieuc, , France
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Toulouse, , France
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Berlin, , Germany
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Cologne, , Germany
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Freiburg im Breisgau, , Germany
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Jena, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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München, , Germany
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Aviano, , Italy
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Barcelona, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Capmobso, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Roma, , Italy
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Aichi, , Japan
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Hyōgo, , Japan
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Tokyo, , Japan
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Środa Wielkopolska, , Poland
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Warzawa, , Poland
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Madrid, , Spain
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Oviedo, , Spain
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Valencia, , Spain
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Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2010-024396-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EudraCT 2010-024396-12
Identifier Type: REGISTRY
Identifier Source: secondary_id
CBEZ235C2201
Identifier Type: -
Identifier Source: org_study_id
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