BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01290406
Recruitment Status : Withdrawn
First Posted : February 7, 2011
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: BEZ235 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: BEZ235 Drug: BEZ235

Primary Outcome Measures :
  1. 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 :
  1. evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) [ Time Frame: every 8 weeks ]
  2. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01290406

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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 )
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Antineoplastic Agents