BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

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

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