EUCTR2012-001038-32-IT进行中（未招募）不适用
A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROOF OF CONCEPTSTUDY OF MAINTENANCE THERAPY WITH TASQUINIMOD IN PATIENTS WITHMETASTATIC CASTRATE-RESISTANT PROSTATE CANCER WHO ARE NOTPROGRESSING AFTER A FIRST LINE DOCETAXEL BASED CHEMOTHERAPY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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)Has provided written informed consent
- •(2)Histologically documented prostate cancer with evidence of
- •metastatic disease on radiological evaluation, with or without symptoms
- •(defined according to the brief pain inventory [BPI] scale, with use of
- •analgesics or narcotics)
- •(3)Has received a first line docetaxel based chemotherapy of 75 mg/m²
- •(as starting dose) every 3 weeks schedule of administration with
- •corticosteroids for a minimum of 6 cycles. Any combination with
- •investigational or non investigational agent is prohibited
- •(4)Male aged =18 years old
- •(5)Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •XML File Identifier: HYGRFmrHY4+xLQPwFSmSfIEZxTA=
- •(6)Docetaxel-related adverse effects must have been resolved to NCICTCAE
- •v4.03 Grade =1. Chemotherapy-induced alopecia and Grade 2
- •peripheral neuropathy are allowed
- •(7)No progressive disease at the end of docetaxel treatment defined
- •according to RECIST criteria, no new lesion(s) assessed by bone scan
- •and no elevated PSA for the three last tests (with the first two PSA
- •values above or equal to the third PSA value). The time between each
- •PSA test should be preferably at least 14 days, however a minimum of 7
- •days is acceptable. The third value will be used for study selection
- •(8)Last dose of docetaxel administered between 21 and 42 days before
- •randomisation
- •(9)Chemical or surgical castration verified by levels of serum
- •testosterone =50 ng/dL (1.75 nmol/L)
- •(10)A life expectancy of at least 12 weeks in the judgment of the
- •Investigator
- •(11)The following laboratory values within 7 days prior to
- •randomisation:
- •Haematology
- •-Absolute granulocytes =1.5 x 109/L
- •-Platelets =100 x 109/L
- •-Haemoglobin =9 g/dL transfusions allowed, epoetin alfa allowed only if
- •last administration >2 weeks before randomisation
- •Biochemistry
- •-Bilirubin =1.5 x upper limit of normal (ULN)
- •-Serum creatinine =1.5 x ULN or calculated creatinine clearance (CrCl)
- •using the Cockcroft-Gault formula =60 mL/min
- •-Alanine aminotransferase/ aspartate aminotransferase =3 x ULN (=5 x
- •ULN if liver metastases present)
- •(12)If sexually active with partner of childbearing potential, patient will
- •agree to use adequate contraceptive method (barrier contraceptive with
- •spermicide) while receiving study treatment and until 14 days after the
- •stop of study treatment or have been previously vasectomised
- •(13)Able to swallow and retain oral drug
- •(14)Able to adhere to the study visit schedule and other protocol
- •requirements
- •(15)Must be available for treatment, evaluation assessments and followup
- •at the study centres
- •(16)Able to comprehend the full nature and purpose of the study,
- 另有 8 项未显示
排除标准
- •(1)Has concurrent use of other anticancer agents or treatm.,with the following exceptions:ongoing treatm. with luteinising hormonereleasing
- •hormone agonists or antagonists,denosumab or
- •bisphosphonate(e.g.zoledronic acid)is permitted if started =4weeks
- •prior to Screening.Ongoing treat. should be kept at a stable dose
- •regimen(2)Has ongoing treatment with warfarin(3)Had prior radiation therapy since starting docetaxel.Exceptions may
- •be made for palliative non-myelosuppressive radiation therapy
- •administered more than 2 weeks prior to randomisation(4)Had prior strontium,samarium or radium therapy or prior treat.with tasquinimod,or any agents with antiangiogenic properties
- •(5)Has ongoing treat.with corticosteroids at>10mg/day
- •prednisolone equivalent(6)Has prostate cancer pain that warrants the initiation of radiotherapy
- •or chemotherapy(7)Has known hypersensitivity to the study treatment,to any of its
- •excipients or treatments with a similar chemical structure(8)Has ongoing treatment with cytochrome P450(CYP)1A2 orCYP3A4
- •metabolised drug substance with narrow therapeutic range at the start
- •of study treatment(9)Has a systemic exposure to ketoconazole or other strong CYP3A4
- •isozyme inhibitors or inducers within 14 days prior to the start of study
- •treatment.Systemic exposure to amiodarone is not permitted within 1year prior to the start of study treatment(10)Has simultaneous participation in any other study involving treatment with investigational drugs or device or has received treatment
- •with investigational drugs less than 4weeks prior to randomisation
- •(11)Has myocardial infarction,percutaneous coronary intervention,acute coronary syndrome,coronary artery bypass graft,New York Heart
- •Association (NYHA)classIII/IV congestive heart failure,cerebrovascular accident,transient ischaemic attack,or limb
- •claudication at rest,within 6 months prior to randomis.and ongoing
- •symptomatic dysrhythmias,unstable angina,uncontrolled hypert.
- •and uncontrolled atrial or ventricular arrhythmias
- •(12)Has history of pancreatitis
- •(13)Has known brain or epidural metastases.Pts with previous
- •medullary cord compression without any neurol.deficit could be
- •included(14)Has known posit.serology for human immunodeficiency virus
- •(15)Has chronic hepat.with advanced,decompensated hepatic
- •disease,cirrhosis of the liver,history of a chronic viral hepatitis or
- •known viral hepatitis carrier(pts who have recovered from
- •hepatitis will be permitted to enter the study)(16)Has active tuberculosis(TB),or with known, untreated latent TB.
- •Country-specific TB therapy should have been given for at least 30days
- •prior to the start of study treatment and patient should intend to
- •complete the entire course of that therapy
- •(17)Has any condition,including other active or latent infections,medical or psychiatric conditions,or the presence of clinically significant
- •laboratory abnormalities,which could confound the ability to interpret
- •data from the study or places the patient at unacceptable risk if he
- •participates in the study
- •(18)Should not participate in the study in the opinion of the Investigator
- •(19)Is currently receiving immunosuppressive therapy
- •(20)Has a history of major surgery 4 weeks prior to randomisation,or
- •has an incompletely healed surgical incision
- •(21)Has a history of other malignancies,except adequately treated nonmelanoma
- •skin cancer or other solid tumours curatively treated,without
- •evidence of disease for>5years
- •(22)Is deprived of his freed
研究者
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