BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
Primary Purpose
Endometrial Cancer
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BEZ235
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial cancer,, uterine cancer,, PI3K,, mTOR,, targeted therapy
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
Sites / Locations
- St. Joseph's Hospital & Medical Center
- Highlands Oncology Group
- City of Hope Medical center
- Holy Cross Hospital
- Henry Ford Hospital
- Morriswon Memorial Hospital
- Carolinas Healthcare Systems
- Cancer Centers of North Carolina
- University of Oklahoma Health Sciences Center
- GHS
- Sarah Gautam Rau
- Texas Oncology, P.A.
- University of Texas Southwestern Medical Center
- STOH
- Pacific Gynecology Specialists
- Cancer Care Northwest
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BEZ235
Arm Description
Outcomes
Primary Outcome Measures
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary Outcome Measures
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).
Full Information
NCT ID
NCT01290406
First Posted
February 3, 2011
Last Updated
June 20, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01290406
Brief Title
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
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial cancer,, uterine cancer,, PI3K,, mTOR,, targeted therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BEZ235
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BEZ235
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
Time Frame
every 8 weeks
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital & Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
City of Hope Medical center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910-1484
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Morriswon Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Carolinas Healthcare Systems
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cancer Centers of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126-0901
Country
United States
Facility Name
GHS
City
Danville
State/Province
Pennsylvania
Country
United States
Facility Name
Sarah Gautam Rau
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1197
Country
United States
Facility Name
Texas Oncology, P.A.
City
Austin
State/Province
Texas
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
STOH
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
Country
Brazil
Facility Name
Novartis Investigative Site
City
Hamilton
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
Country
Canada
Facility Name
Novartis Investigative Site
City
Vancouver
Country
Canada
Facility Name
Novartis Investigative Site
City
Bordeaux
Country
France
Facility Name
Novartis Investigative Site
City
Caen Cedex
Country
France
Facility Name
Novartis Investigative Site
City
La Roche sur Yon Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
Country
France
Facility Name
Novartis Investigative Site
City
Nice
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Brieuc
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 3
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Jena
Country
Germany
Facility Name
Novartis Investigative Site
City
Koln
Country
Germany
Facility Name
Novartis Investigative Site
City
Lubeck
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative Site
City
Munchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Aviano
Country
Italy
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
Country
Italy
Facility Name
Novartis Investigative Site
City
Capmobso
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
Country
Italy
Facility Name
Novartis Investigative Site
City
Aichi
Country
Japan
Facility Name
Novartis Investigative Site
City
Hyogo
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
Country
Japan
Facility Name
Novartis Investigative Site
City
Sroda Wielkopolska
Country
Poland
Facility Name
Novartis Investigative Site
City
Warzawa
Country
Poland
Facility Name
Novartis Investigative Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
Country
Singapore
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative Site
City
Oviedo
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
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