BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

June 20, 2012 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Novartis Investigative Site
      • Sao Paulo, Brazil
        • Novartis Investigative Site
  • Canada
      • Hamilton, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Toronto, Canada
        • Novartis Investigative Site
      • Vancouver, Canada
        • Novartis Investigative Site
  • France
      • 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, France
        • Novartis Investigative Site
  • Germany
      • 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, Germany
        • Novartis Investigative Site
  • Italy
      • 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, Italy
        • Novartis Investigative Site
  • Japan
      • Aichi, Japan
        • Novartis Investigative Site
      • Hyogo, Japan
        • Novartis Investigative Site
      • Tokyo, Japan
        • Novartis Investigative Site
  • Poland
      • Sroda Wielkopolska, Poland
        • Novartis Investigative Site
      • Warzawa, Poland
        • Novartis Investigative Site
  • Russian Federation
      • St. Petersburg, Russian Federation
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain
        • Novartis Investigative Site
      • Oviedo, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
  • Turkey
      • Istanbul, Turkey
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital & Medical Center
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
    • Maryland
      • Silver Spring, Maryland, United States, 20910-1484
        • Holy Cross Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morriswon Memorial Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas HealthCare Systems
      • Raleigh, North Carolina, United States, 27607
        • Cancer Centers of North Carolina
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73126-0901
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Danville, Pennsylvania, United States
        • GHS
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1197
        • Sarah Gautam Rau
    • Texas
      • Austin, Texas, United States
        • Texas Oncology, P.A.
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • San Antonio, Texas, United States
        • STOH
    • Washington
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEZ235
Drug: BEZ235

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: every 8 weeks
every 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
Time Frame: every 8 weeks
every 8 weeks
evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).
Time Frame: Treatment start until 30 days after the last dose
Treatment start until 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBEZ235C2201
  • 2010-024396-12 (EudraCT Number)
  • EudraCT 2010-024396-12 (Registry Identifier: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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