Know Cancer

forgot password

A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

December 2017

Related Keywords:

  • Endometrial Cancer
  • Endometrial cancer,
  • uterine cancer,
  • PI3K,
  • mTOR,
  • targeted therapy
  • Carcinoma
  • Endometrial Neoplasms
  • Adenoma



Henry Ford Hospital Detroit, Michigan  48202
Texas Oncology, P.A. Dallas, Texas  75246
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
City of Hope Medical Center Duarte, California  91010
Pacific Gynecology Specialists Seattle, Washington  98104
Highlands Oncology Group Springdale, Arkansas  72764
Cancer Care Northwest Spokane, Washington  99202
University of Texas Southwestern Medical Center Dallas, Texas  
Holy Cross Hospital Silver Spring, Maryland  20910
Cancer Centers of North Carolina Raleigh, North Carolina  27607
St. Joseph's Hospital & Medical Center Phoenix, Arizona  85013
Morriswon Memorial Hospital Morristown, New Jersey  07960
Carolinas Healthcare Systems Charlotte, North Carolina  28203
GHS Danville, Pennsylvania  
Sarah Gautam Rau Nashville, Tennessee  37203-1197
STOH San Antonio, Texas