BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
- Registration Number
- NCT01290406
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Female ≥ 18 years
- 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
- Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
- 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
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BEZ235 BEZ235 -
- Primary Outcome Measures
Name Time Method assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) every 8 weeks
- Secondary Outcome Measures
Name Time Method evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) every 8 weeks evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious). Treatment start until 30 days after the last dose
Trial Locations
- Locations (17)
Cancer Centers of North Carolina
🇺🇸Raleigh, North Carolina, United States
Novartis Investigative Site
🇹🇷Istanbul, Turkey
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Carolinas Healthcare Systems
🇺🇸Charlotte, North Carolina, United States
GHS
🇺🇸Danville, Pennsylvania, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Gautam Rau
🇺🇸Nashville, Tennessee, United States
STOH
🇺🇸San Antonio, Texas, United States
Texas Oncology, P.A.
🇺🇸Austin, Texas, United States
Pacific Gynecology Specialists
🇺🇸Seattle, Washington, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
City of Hope Medical center
🇺🇸Duarte, California, United States
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Morriswon Memorial Hospital
🇺🇸Morristown, New Jersey, United States