EUCTR2011-004903-20-NL进行中（未招募）不适用
Hydroxychloroquine as an anti-autophagy and chromatin modulating drug in combination with erlotinib in non-small cell lung cancer (NSCLC) patients: a single-center single arm open-label phase II trial - Hydroxychloroquine and erlotinib in NSCLC
未提供0 个研究点目标入组 136 人开始时间: 2012年2月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- •Histologically confirmed stage IV non-squamous NSCLC patients.
- •Patients:
- •with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy.
- •who failed after at least one line of platinum based doublet chemotherapy and who are EGFR TKI naïve.
- •At least one measurable disease site, defined as a lesion of = 1 cm in at least one dimension on CT-scan.
- •WHO performance status 0-2.
- •No symptomatic brain metastases.
- •Absolute neutrophil count of at least 1500/µl, platelet count of at least 100000/µl and hemoglobin level at least 6 mmol/l.
- •Calculated creatinine clearance of at least 60 ml/min.
- •Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN); ALT, AST, and alkaline phosphatase = 2.5 x ULN (in case of liver metastases = 5 x ULN).
- •Willing and able to comply with the study prescriptions
- •18 years or older.
- •Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.
- •Ability to give and having given written informed consent before patient registration.
- •No recent (< 3 months) severe (NYHA class >1) cardiac disease (congestive heart failure, infarction). No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 4.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
- •No cardiac conduction disturbances or medication potentially causing them: congenital long QT-syndrome or unexplained sudden death of first degree relative under 40 years of age, QT interval > 480 msec (note: when this is the case on screening ECG, the ECG may be repeated twice. If the average QT-interval of these 3 measurements remains below 480 msec, patient is eligible). Patients on medication potentially prolonging the QT-interval are excluded if the QT-interval is > 460 msec. Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed. Drugs with a risk of prolonging the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician.
- •No uncontrolled infectious disease.
- •No clinically significant gastrointestinal abnormalities.
- •No other active malignancy.
- •No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
- •No treatment with investigational drugs in the 4 weeks prior to or during this study that are thought or known to interact with autophagy or the EGFR axis.
- •No known G6PD deficiency.
- •No psoriasis or porphyria.
- •No known hypersensitivity to 4-aminoquinoline compound.
- •No retinal or visual field changes from prior 4-aminoquinoline compound use.
- •No known prior hypersensitivity to erlotinib, HCQ or any of their components.
- •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
- •We refer to the inclusion criteria
研究者
相似试验
已完成
2 期
Hydroxychloroquine as an anti-autophagy and chromatin modulating drug in combination with erlotinib in non-small cell lung cancer (NSCLC) patients: a single-center single arm open-label phase II trialAdvanced stage NSCLCMetastatic NSCLC10038666NL-OMON37508Vrije Universiteit Medisch Centrum136
已完成
不适用
Hydroxychloroquine and erlotinib in NSCLC.histologically confirmed stage IV non-squamous NSCLC patients who are eligible to start with EGFR targeted therapy1.patients who progressed on erlotinib or gefitinib monotherapy after having experienced an initial response.2.patients who failed chemotherapy after at least one line of platinum based doublet chemotherapy and who are EGFR TKI naïveDutch:Histologisch bewezen stadium IV non-squamous NSCLC patienten.• Patienten:• met een activerende EGFR mutatie die progressief zijn onder erlotinib of gefitinib monotherapie.OF• welke progressieve ziekte hebben na eerdereNL-OMON21406VU University Medical Center136
进行中（未招募）
1 期
Autophagy inhibition using hydrochloroquine in breast cancer patients: a pilot study - HCQ TRIAEUCTR2010-022842-26-NLniversity Medical Centre Nijmegen20
招募中
2 期
Autophagy inhibition using hydrochloroquine in breast cancer patients: a pilot study10006291breast cancerNL-OMON34049niversitair Medisch Centrum Sint Radboud20
已完成
不适用
Chloroquine as an anti-autophagic chemosensitizing drug in stage IV small cell lung cancer (SCLC) patients: A phase I trial.10029107small cell lung cancerNL-OMON37990MAASTRO clinic24