EUCTR2010-024011-14-IT进行中（未招募）不适用
An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- All
入选标准
- •1. Patient has signed the general Informed Consent Form (ICF) prior to any screening procedures being performed
- •2. Patient is = 18 years of age on the day of consent signature 3. Patient has a histologically confirmed diagnosis of NSCLC with activated PI3K pathway
- •as defined by PIK3CA mutation and/or PTEN mutation an/or PTEN Negative (<10%
- •protein expression by IHC)4. Note: a representative archival or fresh tumor biopsy must be available for shipping to a Novartis designated lab for molecular profiling 5. Patient has experienced objective progressive disease after the prior systemic
- •antineoplastic treatment(s) for advanced NSCLC is/are required as follows: a. Group 1: Diagnosis of squamous NSCLC that progressed after one prior systemic platinum based chemotherapy-line for metastatic disease b. Group 2: Diagnosis of non-squamous NSCLC that progressed after one to two prior systemic antineoplastic therapy lines for metastatic disease Note: a prior systemic therapy line is defined as any prior systemic antineoplastic treatment
- •followed by disease progression; e.g. A first-line treatment for metastatic disease followed (without any disease progression) by a maintenance therapy (e.g. pemetrexed or erlotinib)
- •counts as one prior line of therapy
- •Note: Patients who have a known EGFR activating mutation (assessed prior to signing the ICF) must have previously been treated with at least one prior EGFR TKI (e.g. erlotinib or gefitinib)
- •6. A representative archival or fresh tumor biopsy must be available for shipping to a Novartis designated laboratory for profiling (See Section 6.1.8.3.1) 7. Patient has measurable and/or non-measurable disease as per RECIST 1.1 criteria (Appendix 8)
- •8. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 2 9. Patient has adequate bone marrow and organ function as defined by the following laboratory values: • Absolutely Neutrophil Count (ANC) = 1.5 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 and creatinine clearance > 45 mL/min (refer to Section 5.1.2.3 for calculation formula) • Total Serum Bilirubin within normal range (or = 1.5 x ULN if liver metastases are present, or total bilirubin = 3.0 x ULN with direct bilirubin within normal range in
- •patients with well documented Gilbert’s Syndrome) • AST and ALT = ULN or < 3.0 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1.Patient has received previous treatment with PI3K inhibitors 2.Patient in Stage 2 only: a. Squamous Patients: previous treatment with docetaxel b. Nonsquamous Patients: previous treatment with docetaxel and pemetrexed 3. Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more
- •than two lines of systemic antineoplastic treatment for metastatic disease (for definition of prior lines of therapy please refer to inclusion criterion 4) 4. Patient with uncontrolled or symptomatic CNS metastases: - Patients with controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases = 28 days (must include radiotherapy and/or surgery) and, if on corticosteroid therapy,
- •should be receiving a stable low dose (e.g. dexamethasone 4 mg or equivalent dose of another corticosteroid for at least 14 days before start of study treatment) 5. Patient with a concurrent malignancy or malignancy within 5 years of study enrollment,(with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous
- •skin cancer or curatively resected cervical cancer) 6. Patient who have not recovered to grade 1 or better from any adverse events (except alopecia) related to previous antineoplastic therapy before screening procedures are
- •initiated 7. 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, 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. 8. Patient is concurrently using any other approved or investigational antineoplastic agent. 9. Patient has received therapeutic radiotherapy = 28 days prior to starting study drug or has
- •not recovered from side effects of such therapy 10. Patient has had major surgery within 28 days prior to starting study drug or who have not
- •recovered from major side effects
- •11. Patient has poorly controlled diabetes mellitus (HbA1c > 8 %)
- •12. 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 arrhythmias requiring a pacemaker or not controlled with medication
- •Conduction abnormality requiring a pacemaker • Valvular disease with documented compromise in cardiac function • Symptomatic pericarditis
- •13. Patient has history of cardiac dysfunction including any of the following; Myocardial infarction documented by 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) •
研究者
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