EUCTR2010-021196-85-NL进行中（未招募）1 期
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer - PROSPECT
BN ImmunoTherapeutics, Inc.0 个研究点目标入组 1,297 人开始时间: 2012年12月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,297
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. Signed Informed Consent
- •2. Men, =18 years of age with documented asymptomatic or minimally
- •symptomatic metastatic castration-resistant prostate cancer.
- •3. Castrate testosterone level < 50 ng/dl
- •4. Documented progressive disease post surgical castration or during
- •androgen suppression therapy or during complete androgen blockade
- •therapy and withdrawal. Documented by either criterion a (Radiological
- •progression), OR criterion b (PSA progression).
- •a. Radiological progression defined as any new/enlarging bone
- •mestatases or new/enlarging lymph node disease, consistent with
- •prostate cancer.
- •b. PSA progression defined by sequence of rising values separated by >
- •1 week (2 separate increasing values) over a threshold minimum of 2.0
- •ng/ml. (PCWG2 PSA eligibility criteria).
- •5. Chemotherapy naïve. No prior chemotherapy for metastatic prostate cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate
- •cancer is permissible if >3 years prior.
- •6. Vaccinia-experienced (previous smallpox vaccination).
- •7. ECOG Performance Score of 0 or 1.
- •8. Life expectancy = 1 year.
- •9. Bone Marrow function:
- •- Absolute neutrophil count = 1,500/mm3
- •- Hemoglobin = 10 g/dL
- •- Platelet count = 100,000/mm3
- •10. Hepatic Function:
- •- AST and ALT = 2.5 times upper limit of normal (ULN)
- •- Bilirubin = 1.5 times ULN
- •11. Renal Function:
- •- Creatinine = 2.0 times ULN
- •12. Currently using a GnRH agonist or antagonist (unless surgically
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
排除标准
- •1. Cancer-related pain requiring scheduled opioid narcotics for control
- •(as needed. = 2x per week is allowed).
- •2. Metastasis to organ systems other than lymph nodes and/or bone.
- •3. LDH = 2 times ULN.
- •4. Alkaline phosphatase = 2 times ULN.
- •5. Estimated PSA doubling time of <1 month as established within 6
- •months of the anticipated first dose of vaccine or placebo. A minimum of
- •3 PSA level determinations, at least 2 weeks apart (over a 6 month time period), are required for assessment.
- •6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for
- •prostate cancer
- •7. Receipt of an investigational agent within 30 days (or 60 days for an
- •antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
- •There is no exclusion to previous experimental therapy provided
- •dosing/treatment is completed at least 30 days prior to the first planned
- •dose of vaccine unless otherwise noted.
- •8. History of prior malignancies other than prostate cancer within the
- •past 3 years, excluding successfully resected basal or squamous cell
- •carcinoma of the skin
- •9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina,
- •ventricular or hemodynamically significant atrial arrhythmia, or
- •cardiovascular disease such as stroke or myocardial infarction (current
- •or within the past 6 months).
- •10. Confirmed positive for HIV, hepatitis B, and /or hepatitis C.
- •11. Prior solid organ or bone marrow transplant
- •12. Immunodeficiency or splenectomy
- •13. Chronic immunosuppressive therapy within 30 days of screening.
- •14. Inflammatory eye disease requiring steroid treatment.
- •15. Chronic administration (defined as daily or every other day for
- •continued use > 14 days) of systemic corticosteroids within 28 days of
- •the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal
- •sprays, and topical creams for small body areas is allowed.
- •16. History of or active autoimmune disease (e.g. autoimmune
- •neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus
- •erythematosis, Sjogren's syndrome, scleroderma, myasthenia gravis,
- •Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or
- •Graves disease). Persons with vitiligo are not excluded. Diabetics are not
- •excluded if the condition is well controlled.
- •17. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin), or GM-CSF. Subjects with a known or suspected allergy to radiological contrast agents are eligible, but this must be noted in the subject's medical history and in the chart notes.
- •18. History of atopic dermatitis or active skin condition (acute, chronic,
- •exfoliative) that disrupts the epidermis.
- •19. Previous adverse reactions to smallpox vaccination.
- •20. Unable to avoid close contact or household contact with the
- •following high-risk individuals for three weeks after the Day 1
- •vaccination or until the vaccination site heals completely: (a) children =
- •3 years of age, (b) pregnant or nursing women, (c) individuals with prior
- •or concurrent extensive eczema or other eczemoid skin disorders, or (d)
- •immunocompromised individuals, such as those with HIV.
- •21. Any condition which, in the opinion of the investigator, would
- •prevent full participation in this trial (including the Long-Term Follow-
- •Up), or would interfere with the evaluation of the trial endpoints
- 另有 1 项未显示
研究者
相似试验
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVRespiratory Syncytial VirusMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-002023-11-HUJanssen-Cilag International NV737
进行中（未招募）
1 期
Efficacy and safety of adding LX4211 (an investigational oral compound) for patients with Type 1 Diabetes Mellitus (T1D) who have inadequate control of their blood glucose (sugar) levels on insulin alone.Type 1 Diabetes MellitusEUCTR2014-005153-39-LTexicon Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVEUCTR2020-002023-11-SEJanssen-Cilag International NV737
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2014-004464-38-NLAmgen Inc852
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)Immunoglobulin A Nephropathy (IgAN)EUCTR2020-003084-26-CZChinook Therapeutics U.S., Inc.320