EUCTR2014-002054-39-DK进行中（未招募）1 期
A randomized, double-blind, placebo-controlled multi-centre phase II study to evaluate efficacy and tolerability of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
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
- Male
入选标准
- •1. Age =18 years at the time of signing the informed consent form.
- •2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- •3. Failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide.
- •4. Evidence of metastatic disease from bone scan (bone lesions) or other imaging modality.
- •5. Evidence of PSA progression in two consecutive determinations at minimum 1 week interval.
- •6. Castrate level of serum testosterone =1.7 nmol/L
- •7. Performance status ECOG 0-2
- •8. Laboratory requirements:
- •Haematology:
- •Neutrophils = 1.5 x 109/l
- •Hemoglobin = 90 g/l
- •Platelets = 100 x 109/l
- •Hepatic function:
- •Total S-bilirubin = 1.5 times the upper limit of normal (ULN)
- •AST (SGOT) / ALT (SGPT) = 2.5 times ULN
- •Renal function:
- •S-creatinine = 1.5 times the upper limit of normal (ULN)
- •Electrolytes:
- •S-sodium, S-potassium, S-calcium (S-albumin corrected), S-phosphate, S-magnesium, all within normal ranges.
- •9. No evidence (= 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
- •10. Able to adhere to the study visit schedule and other protocol requirements.
- •11. Life expectancy =6 months
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •1. Concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of LHRH agonist/antagonist or polyestradiol phosphate bicalutamide. Washout period bicalutamide 6 weeks; after flutamide 4 weeks; abirateron / enzalutamide 6 weeks.
- •2. Any treatment modalities involving chemotherapy, radiation or major surgery within 4 weeks prior to treatment in this study.
- •3. Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
- •4. Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
- •5. Plasma glucose level =7 mmol/l (or >120 mg/dl) at screening.
- •6. Known brain metastases.
- •7. Dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.
- •8. Treatment with bisphosphonates within 4 weeks prior to first dose of study medication.
研究者
相似试验
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab in Psoriatic Arthritis and axial Spondyloarthritis patients withactive enthesitis including one Achilles tendon site (ACHILLES)Psoriatic arthritisAxial spondyloarthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2016-000972-91-GBovartis Pharma Services AG204
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis.on-radiographic axial spondyloarthritisMedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859EUCTR2015-001106-33-ITOVARTIS PHARMA SERVICES AG555
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritisEUCTR2015-001106-33-ESovartis Farmacéutica S.A.555
进行中（未招募）
1 期
Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)Primary Sjogren’s syndromeMedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2016-003292-22-DEovartis Pharma AG180
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab in Psoriatic Arthritis and axial Spondyloarthritis patients with active enthesitis including one Achilles tendon site (ACHILLES)Psoriatic arthritis Axial spondyloarthritisMedDRA version: 19.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2016-000972-91-SKovartis Pharma Services AG200