EUCTR2012-005541-21-IT进行中（未招募）1 期
A dose-finding phase Ib study followed by a randomized, double-blindphase II study of carboplatin and paclitaxel with or without buparlisib inpatients with previously untreated metastatic non-small cell lung cancer(NSCLC) of squamous histology
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
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
- •-Patient has histologically and/or cytologically confirmed diagnosis of
- •squamous NSCLC. Diagnosis of mixed squamous and non-squamous or
- •adenosquamous NSCLC will be acceptable for enrollment.
- •- Patient has archival or fresh tumor tissue for the exploratory
- •analysis of biomarkers related to sensitivity to PI3K
- •inhibitors.
- •- Tumor is Stage IV or Stage IIIb (with malignant pleural or pericardial
- •effusion) at the time of signed informed consent (UICC/AJCC version 7)
- •-Patient has measurable or non-measurable disease according to
- •RECIST v1.1 criteria (for the Phase II portion, the patient must have
- •measurable disease according to RECIST 1.1 criteria)
- •- Patient has an Eastern Cooperative Oncology
- •Group (ECOG) performance status = 1 that the investigator
- •believes is stable at the time of screening
- •- Patient has adequate bone marrow and organ function
- •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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •- Patient has received any prior systemic therapies for metastatic NSCLC.
- •Study treatment in this clinical trial must be the patient's first systemic
- •treatment for metastatic NSCLC. Patients are eligible if they received
- •neo-adjuvant or adjuvant systemic therapy followed by a disease-free
- •interval exceeding 12 months.
- •- Patient has symptomatic CNS metastases [patients with asymptomatic
- •CNS metastases may participate in this trial. The patient must have
- •completed any prior local treatment for CNS
- •metastases = 28 days prior to the start of study treatment
- •(including radiotherapy and/or surgery, or =14 days for
- •stereotactic radiosurgery)].
- •- Patient is currently receiving warfarin or other coumadin derived
- •anticoagulant for treatment, prophylaxis or otherwise. Therapy with
- •heparin, low molecular weight heparin (LMWH), or fondaparinux is
- •- Patient is currently receiving treatment with drugs known to be
- •moderate or strong inhibitors or inducers of isoenzyme CYP3A. The
- •patient must have discontinued strong inducers for at least one week
- •and must have discontinued strong inhibitors before the treatment is
- •initiated. Switching to a different medication prior to
- •randomization is allowed.
- •- Patient has a 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 (e.g. risk of doing harm to self or others) or patients
- •with active severe personality disorders (defined according to DSM- IV)
- •are not eligible. Note: for patients
- •with psychotropic treatments ongoing at baseline, the dose and the
- •schedule should not be modified within the previous 6 weeks prior to
- •start of study drug
- •- Patient has = CTCAE grade 3 anxiety
- •- 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) -
- •Patient who does not apply highly effective
- •contraception during the study and through the duration as
- •defined below after the final dose of study treatment.
研究者
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