Endometrial Cancer
Conditions
Keywords
Endometrial cancer,, uterine cancer,, PI3K,, mTOR,, targeted therapy
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.
Interventions
DRUGBEZ235
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) | every 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) | every 8 weeks |
| evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious). | Treatment start until 30 days after the last dose |
Countries
Brazil, Canada, France, Germany, Italy, Japan, Poland, Russia, Singapore, Spain, Turkey (Türkiye), United States
Outcome results
None listed