BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

Novartis

Status and phase

Withdrawn

Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: BEZ235

Study type

Interventional

Funder types

Industry

Identifiers

NCT01290406

EudraCT 2010-024396-12 (Registry Identifier)

2010-024396-12 (EudraCT Number)

CBEZ235C2201

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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