Clinical trial NCT01290406: BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
Official title: A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: Endometrial cancer,
uterine cancer,
PI3K,
mTOR,
targeted therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: every 8 weeks
Secondary outcomes:
measure: evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
timeFrame: every 8 weeks
measure: evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).
timeFrame: Treatment start until 30 days after the last dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Medical center
state: California
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Morristown
country: United States
facility: Morriswon Memorial Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Healthcare Systems
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Danville
country: United States
facility: GHS
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Gautam Rau
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: STOH
state: Texas
city: Seattle
country: United States
facility: Pacific Gynecology Specialists
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Hamilton
country: Canada
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen Cedex
country: France
facility: Novartis Investigative Site
city: La Roche sur Yon Cedex
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Saint-Brieuc
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 3
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Koln
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Aviano
country: Italy
facility: Novartis Investigative Site
city: Barcelona
country: Italy
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Capmobso
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Modena
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Aichi
country: Japan
facility: Novartis Investigative Site
city: Hyogo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Sroda Wielkopolska
country: Poland
facility: Novartis Investigative Site
city: Warzawa
country: Poland
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Oviedo
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: