EUCTR2010-020802-13-GB进行中（未招募）1 期
A Randomized, Placebo-Controlled, Double-Blind, Phase 3Study Evaluating the Pain Palliation Benefit of AddingCustirsen to a Taxane for Second-line Chemotherapy in Menwith Castrate Resistant Prostate Cancer - The prostate cancer Saturn study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 292
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=18years on the date of consent
- •2.Histological or cytological diagnosis of adenocarcinoma of the prostate
- •3.Metastatic disease at screening on a chest, abdomen or pelvic CT or bone scan
- •4.Concurrent pain and analgesic use that is viewed by the Investigator to be related to prostate cancer
- •5.Received at least 4cycles of prior docetaxel-based first-line chemotherapy for metastatic disease based on a q3 week schedule of docetaxel(NOTE:patients treated on a weekly or alternate schedule for first-line docetaxel must have received an accumulated dose of docetaxel of at least 300mg/M2)
- •6.For patients to receive docetaxel retreatment,a response during first-line docetaxel therapy as defined by one or more of the following must have occurred:
- •a.At least a 30%decrease in the sum of the longest diameter of measurable lesions with no unequivocal progression of existing lesions and no appearance of any new lesions.Measurable disease is defined as either nodes=20 mm or visceral/soft tissue lesions=10 mm
- •b.PSA response(30% reduction compared to the baseline level prior to initiating first-line docetaxel therapy)
- •c.Clinical response(classified by the treating Physician or Investigator as a reduction in pain or analgesic use or improvement in performance status).The type and basis of the clinical response(s) must be determined by the Investigator when obtaining the disease history
- •7.Current progressive disease during or after completing first-line docetaxel treatment as defined by one or more of the criteria below:
- •a.Progressive measurable disease:at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed –or the appearance of one or more new lesions as assessed by CT scan during or after completing first-line docetaxel treatment. Measurable lesions include nodal lesions=20 mm in diameter or visceral/soft-tissue lesions=10 mm in diameter.OR
- •b.Bone Scan Progression:appearance of 2 or more new lesions on bone scan during or after completing first-line docetaxel treatment.OR
- •c.Increasing serum PSA level:Three increasing PSA measurements obtained during or after completing first-line docetaxel treatment and at least one week apart are required.If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 5.0 ng/mL is required for study randomization
- •8.Baseline laboratory values at screening visit:
- •a.Creatinine=1.5xupper limit of normal (ULN)
- •b.Bilirubin=1.1 x ULN (unless elevated secondary to conditions such as Gilbert’s disease)
- •c.SGOT (AST)=1.5 x ULN
- •d.Castrate serum testosterone level (<50 ng/dL-or-<1.7 nmol/L).
- •9.Must be willing to continue primary androgen suppression with luteinizing hormone releasing hormone (LHRH) analogues throughout the study, if not treated with bilateral orchiectomy
- •10.Adequate bone marrow function defined as ANC=1.5 x 109 cells /L and platelet count=100 x 109 /L at screening visit
- •11.Karnofsky score=70%(See Appendix 16.2) at screening visit
- •12.For patients to receive docetaxel retreatment, at least 6 weeks has passed since receiving the last dose of docetaxel at the time of randomization
- •13.At least 21days have passed since completing radiotherapy at the time of randomization
- •14.At least 21days have passed since completing any cytotoxic agent or investigational agent, including ASOs(except custirsen which is an exclusion criterion), at the time of randomization
- •15.Has recovered from any do
排除标准
- •1.More than two interruptions in first-line docetaxel therapy. An
- •interruption will be defined as more than 6 weeks between doses.
- •2.For patients receiving docetaxel retreatment, evidence of disease
- •progression while on or within 6 weeks of receiving the last dose of firstline
- •docetaxel therapy based on one of the following:
- •a.Radiographic imaging (at least a 20% increase in the sum of the
- •longest diameters of measurable lesions over the smallest sum observed
- •–or the appearance of one or more new lesions as assessed by CT scan
- •or = 2 new lesions on bone scan. Measurable disease is defined as either
- •nodes = 20 mm or visceral/soft tissue lesions =10 mm.)
- •b.Clinical deterioration (determined by the treating Physician or
- •Investigator, when obtaining the disease history, such as clinically
- •significant pain progression or decreased performance status).
- •NOTE:Patients with increasing PSA levels while receiving first-line docetaxel are not excluded.
- •3.Life expectancy less than 12 weeks.
- •4.Previously participated in any clinical trial evaluating custirsen.
- •5.Received any other cytotoxic chemotherapy as a second-line treatment after first-line docetaxel-based therapy.
- •6.Not on any opioid analgesic regimen for their prostate cancer-related
- •7.Receiving more than one drug within each of the separate categories
- •of long-acting opioid, short-acting opioid, and non-opioid (See Section
- •8.Receiving any analgesic specified in Appendix 16.7.1 as unacceptable
- •for this study.
- •9.Received any cycling or intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of the continuous
- •LHRH analogues required in Inclusion Criteria #9.
- •10.History of, or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging in asymptomatic patients is not required.)
- •11.Known epidural disease unless it has been treated and there is no
- •progression in the treated area.
- •12.Requiring ongoing treatment during the study with St John's Wort, or with medications known to be either strong CYP3A inhibitors or strong CYP3A inducers (Refer to Section 6.6.11).
- •13.Active second malignancy (except non melanomatous skin or
- •superficial bladder cancer) defined as requiring cancer therapy or at high
- •risk of reoccurrence during the study.
- •14.Uncontrolled or acute medical conditions such as myocardial
- •infarction, congestive heart failure, stroke or treatment of a major active infection within 3 months prior to randomization, as well as current uncontrolled hypertension, angina or a serious arrhythmia; and/or significant concurrent medical illness that in the opinion of the
- •Investigator would preclude protocol therapy.
- •15.Planned concomitant participation in another clinical trial of an
- •experimental agent, vaccine or device. Concomitant participation in
- •observational studies is acceptable.
- •16.Inability to communicate and read in English, Spanish or French.
- •Note:Upon review of source documentation, enrollment of a patient who
- •did not meet the inclusion or exclusion criteria will be classified as a
- •protocol violation.
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