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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary Outcome
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
Condition
Endometrial Cancer
Intervention
BEZ235
Study Arms / Comparison Groups
BEZ235
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
March 2012
Completion Date
December 2017
Primary Completion Date
September 2014
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01290406
Organization ID
CBEZ235C2201
Secondary IDs
2010-024396-12
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
June 2012