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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
N/A
Not Enrolling
Female
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBEZ235C2201

NCT ID:

NCT01290406

Start Date:

March 2012

Completion Date:

December 2017

Related Keywords:

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

Name

Location

Henry Ford HospitalDetroit, Michigan  48202
Texas Oncology, P.A.Dallas, Texas  75246
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
City of Hope Medical CenterDuarte, California  91010
Pacific Gynecology SpecialistsSeattle, Washington  98104
Highlands Oncology GroupSpringdale, Arkansas  72764
Cancer Care NorthwestSpokane, Washington  99202
University of Texas Southwestern Medical CenterDallas, Texas  
Holy Cross HospitalSilver Spring, Maryland  20910
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
St. Joseph's Hospital & Medical CenterPhoenix, Arizona  85013
Morriswon Memorial HospitalMorristown, New Jersey  07960
Carolinas Healthcare SystemsCharlotte, North Carolina  28203
GHSDanville, Pennsylvania  
Sarah Gautam RauNashville, Tennessee  37203-1197
STOHSan Antonio, Texas