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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BEZ235
Drug: BEZ235

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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