Randomized, double-blind, placebo controlled phase II study comparing the safety of MDX-010 BMS-734016 administered with or without prophylactic oral budesonide Entocort EC in patients with unresectable stage III or IV malignant melanoma. - ND

BRISTOL-M.SQUIBB0 个研究点目标入组 100 人开始时间: 2006年4月21日最近更新: 2012年4月3日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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

•Signed written informed consent a Voluntary signed and dated institutional review board IRB /independent ethics committee IEC approved informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performing protocol-related procedures that are not part of standard patient care. 2 Target population a Able to comply with visits/procedures required by the protocol. b Life expectancy of at least 4 months. c ECOG performance status score 0-1 Appendix 1 . d Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma excluding ocular melanoma . e Measurable disease as defined in Section 3.3.3.2. f At least 4 Weeks must have elapsed since the last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery and the beginning of protocol therapy. At least 6 Weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. g Toxicity related to prior therapy must either have returned to 8804; grade 1, baseline, or been deemed irreversible. Men and women, ages 18 and above.
•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

•Sex and Reproductive Status a WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study. b WOCBP using a prohibited contraceptive method. c Women who are pregnant or breastfeeding. d Women with a positive pregnancy test on enrollment or prior to study drug administration. e Sexually active fertile men who are unwilling or unable to use a barrier contraceptive eg, condom or whose partners are WOCBP not using a method of birth control from the time of enrollment and for 12 Weeks after participation in the study. 2 Target Disease Exclusion a Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix. b Ocular melanoma. 3 Medical History and Concurrent Diseases a Active, untreated central nervous system CNS metastasis including metastasis identified during screening MRI or contrast CT . b Autoimmune disease Patients with a history of Inflammatory Bowel Disease are excluded from this study as are patients with a history of autoimmune disease e.g. Systemic Lupus Erythematosus, vasculitis, infiltrating lung disease whose possible progression during treatment would be considered by the Investigator to be unacceptable. Patients with a history of well-controlled and/or clinically manageable autoimmune disease e.g. vitiligo, well-controlled thyroid disease, mild psoriasis may be considered for inclusion in consultation with the BMS Medical Monitor. c Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea; d Positive screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can be admitted after discussion with and agreement by the BMS Medical Monitor. Prohibited Therapies and/or Medications a Exposure to any investigational products within 4 Weeks prior to Day 1 of treatment.

研究者

发起方

BRISTOL-M.SQUIBB

相似试验

已完成

1 期

Phase Ib-IIb trial of the live oral cholera vaccine 638 in adult volunteers in Mozambique.Cholera diseaseCholera/ prevention & controlHealthy VolunteersVibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsWaterborne DiseasesEnvironmental Illness

RPCEC00000051Finlay Institute120

进行中（未招募）

不适用

Abatacept treatment in primary Sjögrens SyndromePrimary Sjögren's syndrome (pSS)MedDRA version: 16.1Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 100000004859

EUCTR2014-000417-31-NLniversity Medical Center Groningen

进行中（未招募）

1 期

Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patientsActive inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.MedDRA version: 8.1Level: LLTClassification code 10021972Term: Inflammatory bowel disease

EUCTR2006-004162-13-DECharité Universitätsmedizin, Campus Charité Mitte40

已完成

3 期

Randomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren*s syndrome (ASAP III study = Abatacept Sjögren Active Patients phase III study)primary Sjögren's syndrome10003816

NL-OMON44430niversitair Medisch Centrum Groningen80

进行中（未招募）

不适用

EUCTR2009-014725-16-DEAIO Studien gGmbH