EUCTR2012-002447-14-IT进行中（未招募）1 期
A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As ASecond-Line Treatment In Patients With Advanced or Metastatic (Stage IV)Non-Small Cell Lung Cancer - ENSPIRIT
TEVA PHARMACEUTICALS INDUSTRIES LTD0 个研究点目标入组 1,100 人开始时间: 2012年12月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,100
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.Patients must have a histologically or cytologically confirmed,
- •unresectable, advanced or metastatic (Stage IV per American Joint
- •Committee on Cancer 7th edition of tumor, nodes and metastases
- •classification of malignant tumors [TNM] staging) NSCLC
- •2.Males or females = 18 years of age at screening.
- •3.Life expectancy of > 12 weeks from screening, according to the Investigator's assessment.
- •4.Patients must have received one prior line of platinum-based systemic
- •anticancer therapy for advanced or metastatic NSCLC. Prior maintenance
- •therapy is allowed and will be considered as the same line of therapy
- •when continued at the end of a treatment regimen.
- •5.Patients must have documented radiological disease progression
- •either during or after the first-line therapy.
- •6.Patients must have at least one measurable lesion per RECIST 1.1
- •7.ECOG PS of 0 or 1 at screening.
- •8.Have adequate bone marrow, renal and liver functions at screening as
- •defined below:
- •-Absolute neutrophil count (ANC) = 1.5 x 109/L
- •-Platelet count = 100 x 109/L
- •-Hemoglobin = 9 g/dL
- •-Serum creatinine = 1.5 x upper limit of normal (ULN)
- •-Total Bilirubin=1.0 x ULN (unless elevated secondary to benign
- •conditions such as Gilbert's disease)
- •-Aspartate transaminase (AST) and alanine transaminase (ALT)=1.5 x
- •9.Resolution of any toxic effects of prior therapy to Grade =1 according
- •to the National Cancer Institute Common Terminology Criteria for
- •Adverse Events (NCI CTCAE), version 4.0 (exception of alopecia and =
- •Grade 2 peripheral neuropathy).
- •10.Females of child-bearing potential must have negative serum
- •pregnancy test within 72 hours before randomization.
- •11.Women of child-bearing potential will practice a highly effective
- •method of birth control during and for 3 months after the
- •chemotherapy/custirsen last dose. Male partners of women of childbearing
- •potential can be either surgically sterile, or will ensure that their
- •female partner utilizes a highly effective contraceptive method during
- •and for 3 months after chemotherapy/custirsen last dose.
- •12.Patients must be willing and able to give written informed consent
- •prior to any protocol-specific procedures being performed and comply
- •with the protocol requirements for the duration of the study
- •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 440
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 660
排除标准
- •1.Patients treated with any systemic anti-cancer therapy for NSCLC
- •within 21 days prior to randomization (6 weeks for bevacizumab).
- •2.Radiotherapy = 2 weeks prior to randomization. Patients must have
- •recovered from all radiotherapy-related toxicities.
- •3.Major surgical procedure within 4 weeks prior to randomization.
- •Patient must have recovered from all surgery-related complications.
- •4.Patients with known central nervous system (CNS) metastases
- •(Patients with any clinical signs of CNS metastases must have a CT or
- •MRI of the brain to rule out CNS metastases in order to be eligible for
- •participation in the study. Patients who have had brain metastases
- •treated with radiotherapy or surgically removed with no residual disease
- •confirmed by imaging should be clinically stable and off corticosteroid
- •treatment at least 3 weeks prior to randomization).
- •5.Patients with current diagnosis or a history of another active primary
- •malignancy (except in situ carcinoma of the cervix, adequately treated
- •non-melanomatous skin cancers, clinically localized prostate cancer,
- •superficial bladder cancer or other malignancy treated at least 5 years
- •previously with no evidence of recurrence).
- •6.Severe or unstable medical conditions such as heart failure, ischemic
- •heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus,
- •psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (= Grade 2, according to NCI CTCAE v4.0) or any
- •other significant or unstable concurrent medical illness that in the
- •opinion of the Investigator would preclude protocol therapy.
- •7.A history of events such as myocardial infarction, cerebrovascular
- •accident (CVA) or acute hepatitis within 3 months of randomization or
- •treatment of a major active infection within one month of randomization,
- •or any other significant event that in the opinion of the Investigator
- •would preclude protocol therapy.
- •8.Planned concomitant participation in another clinical trial of an
- •experimental agent, vaccine, or device. Concomitant participation in
- •observational studies is acceptable.
- •9.Female patients who are breastfeeding.
- •10.Patients previously treated with docetaxel for NSCLC or with known
- •severe hypersensitivity to taxane therapies.
研究者
相似试验
进行中（未招募）
1 期
A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy.on-Small Cell Lung Cancer stage IVMedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002447-14-ESTeva Pharmaceutical Industries, Ltd1,100
进行中（未招募）
1 期
A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy.on-Small Cell Lung Cancer stage IVMedDRA version: 19.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002447-14-HUOncoGenex Technologies Inc660
进行中（未招募）
1 期
A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy.EUCTR2012-002447-14-DEOncoGenex Technologies Inc.660
进行中（未招募）
1 期
A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy.on-Small Cell Lung Cancer stage IVMedDRA version: 19.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002447-14-PLOncoGenex Technologies Inc660
已完成
3 期
Study to determine if contacting patients with Medullary Thyroid Cancer (MTC) more frequently results in earlier detection and treatment of signs and symptoms of AEs and thus a decrease in the percentage of time patients experience AEs during first 12 months on vandetanib treatment.CTRI/2011/07/001930AstraZeneca12