EUCTR2010-022015-19-DE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
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
- •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
- •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:
- •5.Patient has at least one measurable lesion as per RECIST criteria (Post-text Supplement 1)
- •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
- •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
- •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 disease (for definition of prior lines of therapy please refer to inclusion criterion 4)
- •3.Patient has symptomatic 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)
- •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
- •11.Patient has a history of cardiac dysfunction
- •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 12-3 in Appendix 3 for a list of prohibited drugs)
- •13.Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •14.Patient receiving chronic treatment with steroids or another immunosuppressive agent.
- •15.Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment contraindicate her participation in the clinical study (e.g., chronic pancreatitis, active chronic hepatitis etc.)
- •16.Patient has a history of non-compliance to medical regimen
- •17.Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. Please refer to Table 12-1 in Appendix 1 for a list of prohibited CYP 3A4 inhibitors and inducers.
- •18.Patient has a known history of HIV (testing not mandatory) infection
- •19.Patient is a pregnant or nursing (lactating) woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test (> 5 mIU/mL)
- •20.Patient is a woman of child-bearing potential,
研究者
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