EUCTR2010-022015-19-IT进行中（未招募）不适用
A Phase II, single-arm study of orally administered BKM120 as second-line therapy in patients with advanced endometrial carcinoma - ND
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
- •1. Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure 2. Patient is a female = 18 years at the day of consenting to the study 3. 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 a fixed fresh biopsy, for identification of PI3K pathway activation • all of the following histological types are eligible: endometrioid, papillary serous, clear cell, papillary endometrioid, mucinous, and adenosquamous • confirmation that the specimen has been collected by the courier service and will be sent to the central lab (e.g., tracking number of courier service) must be communicated to the sponsor prior to enrolling the patient into the treatment phase of the trial 4. Patient has experienced objective progression of disease after first-line antineoplastic treatment for advanced endometrial carcinoma as defined by the investigator. One prior line of antineoplastic treatment is defined as: • First-line treatment for advanced disease including at least one cytotoxic agent. Note: any adverse events related to prior therapy must have returned to grade = 1 (except alopecia) before screening procedures are initiated • Any adjuvant treatment is generally not considered a prior line of treatment unless the recurrence occurred while on adjuvant chemotherapy or = 6 months since the last administration of adjuvant chemotherapy (with the exception of endocrine treatments), • Any prior hormonal treatment is not considered a line of treatment in any setting 5. Patient has at least one measurable lesion as per RECIST criteria (Appendix 5) 6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 2 7. Patient has adequate bone marrow and organ function as defined by the following laboratory values: • Absolute Neutrophil Count (ANC) = 1.0 x 109/L • Platelets = 100 x 109/L • Hemoglobin = 9.0 g/dL • INR = 2 - Potassium, calcium, magnesium within normal limits for the institution • Serum Creatinine = 1.5 x ULN • Serum Bilirubin = 1.5 x ULN (in patients with known Gilbert Syndrome, total bilirubin = 3 x ULN, with direct bilirubin = 1.5 x ULN) • AST and ALT = 2.5 x ULN or = 5.0 x ULN if liver metastases are present • Fasting plasma glucose (FPG) = 120 mg/dL or = 6.7 mmol/L
- •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
- •Patient has received previous treatment with PI3K and/or mTOR inhibitors 2. Patient has received more than one line of antineoplastic treatment for advanced disease (for definition of prior lines of therapy please refer to inclusion criterion 4) 3. Patient has symptomatic CNS metastases • 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. 4. Patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer) 5. Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of = 10 in the PHQ-9 or a cut-off of = 15 in the GAD-7 mood scale, respectively, or selects a positive response of ‘1, 2, or 3’ to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9) • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) • = CTCAE grade 3 anxiety 6. Patient is concurrently using other approved or investigational antineoplastic agent (hormonal agents included) 7. Patient has received pelvic and/or para-aortic radiotherapy = 28 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. 8. Patient has had major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery 9. Patient has poorly controlled diabetes mellitus (HbA1c > 8 %) 10. 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 • Angina pectoris that requires the use of anti-anginal medication • Ventricular arrhythmias except for benign premature ventricular contractions • Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication • Conduction abnormality requiring a pacemaker • Valvular disease with documented compromise in cardiac function • Symptomatic pericarditis 11. Patient has a history of cardiac dysfunction including any of the following; • Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function • History of documented congestive heart failure (New York Heart Association functional classification III-IV) • Documented cardiomyopathy 12. Patient is currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (see Section 5.1.5.3 and Table 13-3 in Appendix 3 for a list of prohibited drugs). See section 4.2 of the protocol for the remaining criteria.
研究者
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