EUCTR2004-000696-34-HU进行中（未招募）不适用
A Phase II study of DJ-927 administered orally once every three weeks as second line therapy to subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of a platinum-based non-taxane regimen - N/A
Daiichi Pharmaceutical Co., Ltd0 个研究点目标入组 37 人开始时间: 2004年7月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 37
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. Histologically and/or cytologically confirmed locally advanced or metastatic NSCLC
- •2. No more than one prior systemic platinum-based (non-taxane) chemotherapy regimen for locally advanced or metastatic NSCLC
- •3. Demonstrated tumour progression at time of entry into study
- •4. Measurable Disease (RECIST). FOr patients who have received prior radiotherapy, measurable disease must be located outside the previously-irradiated field
- •5. Age 18 years or over
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •7. Reasonable survival expectation greater than or equal to 12 weeks
- •8. Adequate bone marrow, liver and renal function defined as:
- •a) absolute neutrophil count greater than or equal to 1.5 x 109/L
- •b) platelet count greater than or equal to 100 x 10 9/L
- •c) AST and ALT less than or equal to 2.5x upper limit of normal (ULN) (or <5x ULN when liver metastases are present)
- •d) total bilirubin value less than or equal to 1.5x ULN
- •e) serum creatinine value less than or equal to 1.5x ULN
- •9. Fully recovered from any previous surgery (at least 4 weeks since major surgery)
- •10. Using double barrier contraception (males and females alike) (if applicable). A negative pregnancy test must be documented at the screening/baseline visit for women of childbearing potential
- •11. Has signed a voluntary written informed consent and has the ability to understand and agree to the requirements of the study
- •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
- •1. No measurable disease
- •2. Continuing toxicities related to previous anti-tumour therapy (e.g., radiation therapies, biological therapies and investigational products), and administration of concurrent or previous myelosuppressive therapy within 4 weeks (or 6 weeks for prior treatment with nitrosourea, mitomycin C or carboplatin)
- •3. Prior taxane therapy
- •4. Prior wide field radiotherapy (>25% of marrow) within the previous 4 weeks, or radiotherapy to limited portals within 2 weeks
- •5. History of known or suspected CNS metastases
- •6. History of other malignancy (except resected non-melanoma skin cancer or resected carcinoma in situ of the cervix), unless in complete remission and off all therapy of that disease for a minimum of 2 years
- •7. Concurrent serious infection
- •8. Concurrent severe or uncontrolled underlying medical disease unrelated to the tumour that is likely to compromise subject safety and affect the outcome of the study
- •9. History of any severe or life-threatening hypersensitivity reaction
- •10. Neurotoxicity greater than or equal to Grade 2
- •11. Pregnant or lactating women
- •12. Clinically significant dysphagia or malabsorption that precludes the ability to comply with oral medication and absorption of DJ-927
- •13. Any contra-indication including extensive intestinal surgery that would impair small intestinal absorption of taxanes
- •Diarrhoea (greater than or equal to Grade 2)
- •14. Currently enrolled in an investigational device or drug trial, or less than 30 days since completing an investigational device or drug trial
- •15. Recent history (within 6 months) of chronic alcohol or drug abuse which may compromise the subject's safety or ability to participate in study activities
- •16. History of psychiatric disorder that prevents subjects from providing informed consent or following protocol instructions
研究者
相似试验
进行中（未招募）
不适用
A phase II study of orally administered RO4929097, a gamma-secretase inhibitor, as a single agent in patients with recurrent or refractory Non-Small Cell Lung Cancer (NSCLC).Patients with recurrent or refractory stage IIIB/IV NSCLC.MedDRA version: 9.1Level: LLTClassification code 10029515Term: Non-small cell lung cancer recurrentMedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVEUCTR2008-006384-37-NLF. Hoffmann-La Roche Ltd
撤回
2 期
A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With MethotrexateActive Rheumatoid Arthritis Rheumatoid ArthritisNCT01480388Janssen Research & Development, LLC
已完成
2 期
A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque PsoriasisPlaque PsoriasisNCT05357755Janssen Research & Development, LLC90
已完成
1 期
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male ParticipantsHealthyNCT02555124Janssen Pharmaceutical K.K.24
招募中
1 期
A Phase 1b Study of JNJ-90014496 in Adult Participants with Relapsed or Refractory B-cellNon-Hodgkin Lymphomaon-Hodgkin Lymphoid MalignanciesCTIS2023-506267-33-00Janssen - Cilag International54