EUCTR2010-024396-12-CZ进行中（未招募）不适用
A Phase II, single-arm study of orally administered BEZ235 as second-line therapy in patients with advanced endometrial carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patient is a female = 18 years at the day of consenting to the study
- •Patient has a histologically confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue (one block or a minimum of 20 unstained slides) or fresh formalin fixed tumor biopsy, for identification of PI3K pathway activation
- •Patient has experienced objective progression of disease on or after first-line anti-neoplastic treatment for advanced or metastatic endometrial carcinoma
- •Patient has recovered (to grade = 1) from all clinically significant toxicities related to prior antineoplastic therapies (with the exception of alopecia) and has adequate bone marrow and organ functions
- •Patient has at least one measurable lesion as per RECIST
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 2 which is not declining during the last 2 weeks before the signature of the main study Informed Consent Form (S-ICF).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient has received previous treatment with PI3K and/or mTOR inhibitors
- •2.Patient has received more than one line of antineoplastic treatment for advanced or metastatic disease (for definition of prior lines of therapy please refer to inclusion criterion 4)
- •3.Patient has active uncontrolled or symptomatic CNS metastases
- •4.Note: Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases > 28 days (including radiotherapy and/or surgery) prior to enrollment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- •5.Patient has a concurrent malignancy or has had a malignancy in the last 3 years prior to start of study treatment (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
- •6.Patient has received pelvic and/or para-aortic radiotherapy = 28 days or limited filed palliative radiotherapy = 14 days prior to enrollment in this study or has not recovered from side effects of such therapy at the time of initiation of screening procedures.
- •7.Patient has had major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery
- •8.Patient has active cardiac disease including any of the following:
- •Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
- •QTc > 480 msec on screening ECG (using the QTcF formula)
- •Unstable angina pectoris
- •Ventricular arrhythmias except for benign premature ventricular contractions
- •Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
- •Conduction abnormality requiring a pacemaker
- •Valvular disease with documented compromise in cardiac function
- •Symptomatic pericarditis
- •9.Patient has a history of cardiac dysfunction 10.Family history of congenital long or short QT, or known history of QT/QTc prolongation or Torsade de Point(TdP)
- •11.Inadequately controlled hypertension(i.e, SBP >180 mmHg or DBP >100mmHg)
- •12.Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea grade = 2, malabsorption syndrome, or small bowel resection)
- •13.Patient is concurrently using other approved antineoplastic or any investigational agents (hormonal agent included) in the last 30 days prior to start of treatment
- •14.Patient receiving chronic treatment with systemic steroids or another immunosuppressive agent at start of study treatment..
- •16.Patient is currently being treated with any of the following drugs:
- •Moderate and strong inhibitors or inducers of CYP3A4/5 (Please refer to Appendix 1 for a list of prohibited CYP3A4 inhibitors and inducers)
- •Drugs with known risk to induce Torsades de Pointes (see Appendix 3 for a list of prohibited drugs)
- •Warfarin or coumarin analogues
- •LHRH agonists
- •17.Patient is consuming Seville oranges, grapefruit, grapefruit hybrids, pummelos and exotic citrus fruits (as well as their juices) during the last 7 days prior to start of treatment. Regular orange juice is permitted
- •18.Immunocompromised patients, including known seropositivity for HIV (testing is not mandatory)
- •19.Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s jud
研究者
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