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BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 3, 2011
Last updated: June 20, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Endometrial Cancer
Drug: BEZ235
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) [ Time Frame: 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 ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BEZ235 Drug: BEZ235


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01290406

  Show 59 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01290406     History of Changes
Other Study ID Numbers: CBEZ235C2201
2010-024396-12 ( EudraCT Number )
EudraCT 2010-024396-12 ( Registry Identifier: EudraCT )
Study First Received: February 3, 2011
Last Updated: June 20, 2012

Keywords provided by Novartis:
Endometrial cancer,
uterine cancer,
targeted therapy

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female processed this record on April 26, 2017