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BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01290406
First received: February 3, 2011
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01290406     History of Changes
Other Study ID Numbers: CBEZ235C2201, 2010-024396-12, EudraCT 2010-024396-12
Study First Received: February 3, 2011
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Columbia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Israël: Ministry of Health
Korea: Food and Drug Administration
Singapore: Health Sciences Authority
Taiwan: Department of Health
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Endometrial cancer,
uterine cancer,
PI3K,
mTOR,
targeted therapy

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013