BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

Endometrial Cancer Clinical Trial

Official title:

A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01290406
• Other study ID #: CBEZ235C2201
• Secondary ID: 2010-024396-12Eu
• Status: Withdrawn
• Phase: Phase 2
• First received: February 3, 2011
• Last updated: June 20, 2012
• Start date: March 2012
• Est. completion date: December 2017

Study information

• Verified date: June 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaColumbia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHong Kong: Department of HealthHungary: National Institute of PharmacyItaly: National Institute of HealthIsraël: Ministry of HealthKorea: Food and Drug AdministrationSingapore: Health Sciences AuthorityTaiwan: Department of HealthThailand: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• BEZ235

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Rio de Janeiro
Brazil	Novartis Investigative Site	Sao Paulo
Canada	Novartis Investigative Site	Hamilton
Canada	Novartis Investigative Site	Montreal
Canada	Novartis Investigative Site	Toronto
Canada	Novartis Investigative Site	Vancouver
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Caen Cedex
France	Novartis Investigative Site	La Roche sur Yon Cedex
France	Novartis Investigative Site	Le Mans
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Saint-Brieuc
France	Novartis Investigative Site	Toulouse Cedex 3
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Koln
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Munchen
Italy	Novartis Investigative Site	Aviano
Italy	Novartis Investigative Site	Barcelona
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Brescia
Italy	Novartis Investigative Site	Capmobso
Italy	Novartis Investigative Site	Milano
Italy	Novartis Investigative Site	Modena
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma
Japan	Novartis Investigative Site	Aichi
Japan	Novartis Investigative Site	Hyogo
Japan	Novartis Investigative Site	Tokyo
Poland	Novartis Investigative Site	Sroda Wielkopolska
Poland	Novartis Investigative Site	Warzawa
Russian Federation	Novartis Investigative Site	St. Petersburg
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Oviedo
Spain	Novartis Investigative Site	Valencia
Turkey	Novartis Investigative Site	Istanbul
United States	Texas Oncology, P.A.	Austin	Texas
United States	Carolinas Healthcare Systems	Charlotte	North Carolina
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	GHS	Danville	Pennsylvania
United States	Henry Ford Hospital	Detroit	Michigan
United States	City of Hope Medical center	Duarte	California
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Morriswon Memorial Hospital	Morristown	New Jersey
United States	Sarah Gautam Rau	Nashville	Tennessee
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Cancer Centers of North Carolina	Raleigh	North Carolina
United States	STOH	San Antonio	Texas
United States	Pacific Gynecology Specialists	Seattle	Washington
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Cancer Care Northwest	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  France,  Germany,  Italy,  Japan,  Poland,  Russian Federation,  Singapore,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)		every 8 weeks	No
Secondary	evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)		every 8 weeks	No
Secondary	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	Yes