An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway - NA

ovartis Pharma Services AG0 个研究点目标入组 180 人开始时间: 2011年7月6日最近更新: 2014年4月14日

适应症

试验速览

暂无简介。

•1. Histologically confirmed NSCLC with activated PI3K pathway
•2. Progressive disease after prior systemicantineoplasic treatment(s) for advanced NSCLC
•3. Archival or fresh tumor biopsy must be available for
•4. Measurable and/or non-measurable disease as per RECIST 1.1 criteria
•(Appendix 8)
•5. Eastern Cooperative Oncology Group (ECOG) performance status = 2
•6. Adequate organ function as assessed by laboratory tests
•Other protocol-defined inclusion criteria may apply
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. Patient has received previous treatment with PI3K inhibitors
•2. 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
•3. Uncontrolled or symptomatic CNS metastases
•4. Concurrent use of any other approved or investigational antineoplastic agent
•5. Radiotherapy = 28 days prior to starting study drug
•6. Major surgery within 28 days prior to starting study drug
•7. History of clinically significant cardiac dysfunction, mood disordre, or poorly controlled diabetes mellitus
•8. Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
•9. Impairment of gastrointestinal (GI) function
•10. Chronic treatment with steroids or another immunosuppressive agent.
•11. Concurrent severe and/or uncontrolled medical condition
•12. Currently receiving Warfarin or another coumarin derivative
•13. Known history of HIV infection
•14. Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
•15. Pregnancy, lactation, or breastfeeding, woman of child-bearing potential
•Other protocol-defined inclusion/exclusion criteria may apply.

发起方