EUCTR2013-000833-11-NO进行中（未招募）1 期
A Phase Ib/II study of docetaxel with or without buparlisib as second line therapy for patients with advanced or metastatic squamous non-small cell lung cancer - Basalt 3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
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 is an adult = 18 years old at the time of informed consent
- •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 received one prior approved regimen of platinum-based chemotherapy (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) squamous NSCLC, followed by disease progression. A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen.
- •Note: Patients who received paclitaxel therapy are eligible for this trial.
- •Patient has adequate tumor tissue (either archival or new tumor biopsy) for the analysis of PI3K-related biomarkers.
- •- Enrollment in the Phase II part of the study is contingent on the central laboratory confirming receipt of an adequate amount of tissue including sufficient DNA for analysis.
- •Patient has measurable or non-measurable disease according to RECIST version 1.1 criteria.
- •- Phase II only: Patient must have at least one measurable lesion as per RECIST criteria.
- •Patient has an ECOG performance status = 1
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient has received previous treatment with a PI3K or AKT inhibitor
- •Patient has symptomatic Central Nervous System (CNS) metastases
- •- Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed prior local treatment, if any, for CNS metastases = 28 days prior to the start of study treatment (including radiotherapy and/or surgery, or = 14 days for stereotactic radiosurgery).
- •Patient has a score = 12 on the PHQ-9 questionnaire.
- •Patient selects a response of 1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9).
- •Patient has a GAD-7 mood scale score = 15.
- •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 or patients with active severe personality disorders.
- •Patient has = CTCAE grade 3 anxiety
研究者
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