EUCTR2010-024011-14-BE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
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
- •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
- •Potassium, calcium, magnesium within normal limits for the institution
- •Serum Creatinine = 1.5 x ULN and creatinine clearance > 45 mL/min (refer to Section5.1.2.3 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:
- •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 inhibitors
- •2. Patient in Stage 2 only:
- •a. Squamous Patients: previous treatment with docetaxel
- •b. Non-squamous 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)
- •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
- •8. Patient is concurrently using any other approved or investigational antineoplastic agent
- •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
- •13. Patient has history of cardiac dysfunction
- •14. Patient is currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
- •15. 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)
- •16. Patient receiving chronic treatment with steroids or another immunosuppressive agent.
- •Note: Topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases),eye drops or local injections (e.g., intra-articular) are allowed. Patients with previously treated brain metastases, who are on a stable low dose corticosteroids treatment (e.g. dexamethasone 4 mg/day or other steroids equivalent dose) for at least 14 days before start of study treatment, are eligible.
- •17. Patient has any other concurrent severe and/or uncontrolled medical condition that would,in the investigator's judgment contraindicate patient participation in the clinical study ?patient participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.)
- •18. Patient has a history of non-compliance to medical regimen and inability to grant consent
- •19. Patient is currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment.
- •20. Patient is currently receiving Warfarin or another coumarin derivative
- •21. Patient has a known history of HIV (testing not mandatory) infection
- •22. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
- •23. Patient is pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
- •25. Patient with uncontrolled or symptomatic CNS metastase
研究者
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