BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
Withdrawn before enrolling · Phase 2
Conditions studied: Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT01290406
- Run by
- Novartis Pharmaceuticals
- People needed
- 0
- Starts
- 2012-03-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2012-06-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Novartis Investigative Site — São Paulo, Brazil
- Novartis Investigative Site — Hamilton, Canada
- Novartis Investigative Site — Montreal, Canada
- Novartis Investigative Site — Toronto, Canada
- Novartis Investigative Site — Vancouver, Canada
- Novartis Investigative Site — Bordeaux, France
- Novartis Investigative Site — Caen, France
- Novartis Investigative Site — La Roche-sur-Yon, France
- St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.