EUCTR2008-000879-26-IT进行中（未招募）不适用
?Double-blind, randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of Sagopilone-induced peripheral Neuropathy? - REASO
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BAYER
- 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
- All
入选标准
- •1)Histologically or cytologically proven
- •a)Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or clear cell tumors) or
- •b)Adenocarcinoma of the prostate
- •Specific for HRPC:
- •2)At least 1 unidimensionally measurable lesion (suitable for RECIST evaluation) or for patients without measurable disease PSA value ≥ 5 ng/mL
- •3)Progression of disease despite adequate androgen-inhibiting hormone therapy, demonstrated by:
- •- rising PSA on at least 2 consecutive measurements taken at least 7 days apart. The last measurement must be 50% greater than the lowest PSA value achieved under the last previous treatment.
- •- PSA at least 5 ng/ml
- •4)PSA value at screening (4 to 6 weeks after cessation of antiandrogen treatment) must continue to be elevated
- •5)Serum testosterone < 50 ng/mL (ongoing treatment with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy)
- •Specific for ovarian cancer
- •6)At least 1 unidimensionally measurable lesion (suitable for RECIST evaluation) or for patients without measurable disease, CA 125 levels ≥ 2 times the upper limit of normal (ULN) within 3 months and confirmed within 2 weeks prior to first infusion.
- •7)Progression of disease or symptomatic relapse after previous therapy (elevated CA 125 levels alone are insufficient for inclusion).
- •All patients
- •8)Males or females aged ≥18 years
- •9)WHO performance status 0 to 1
- •10)No clinical residual neuropathy (CTCAE Grade 0 at baseline)
- •11)Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
- •12)Adequate function of major organs and systems
- •Hematopoietic:
- •-Hemoglobin:>/= 10 g/dL
- •-WBC:>/= 3,000/mm3
- •-Absolute neutrophil count:>/=1,000/mm3
- •-Platelet count:>/=100,000/mm3
- •-Total bilirubin:normal
- •AST/ALT:Renal:
- •-Creatinine:Cardiovascular:
- •-No symptomatic congestive heart failure
- •-No unstable angina pectoris
- •-No arrhythmia needing continuous treatment
- •-No uncontrolled hypertension
- •-No MI within past 6 months
- •-No cerebrovascular insult within past 6 months
- •No other uncontrolled concurrent illness
- •13)Survival expectation >/= 3 months
- •14)Negative pregnancy test at enrollment (females of childbearing potential only)
- •15)Agreement to use highly effective contraception methods (intra-uterine contraceptive device IUCD, condoms, oral contraceptives, or other adequate barrier contraception) in females of child-bearing potential and adequate barrier birth control measures in men during the course of the trial and two weeks after the completion of the trial.
- •16)Written informed consent
- •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
- •1)Candidacy for curative resection
- •2)Symptomatic brain metastases requiring whole-brain irradiation
- •3)Congenital bleeding diathesis, acquired coagulopathy or patients receiving full dose of anticoagulants for the treatment of thromboembolism
- •4)Any concomitant malignancy: the following exceptions are allowed:
- •a)Non-melanoma skin cancer
- •b)Carcinoma in situ of the cervix
- •c)Malignancy with definitive treatment ≥ 5 years ago without relapse
- •5)History of organ allograft
- •6)Diabetes mellitus (even if controlled only by special diet)
- •7)History of chronic hepatitis B or C or known HIV infection
- •8)Seizure disorder requiring medication (such as steroids or anti-epileptics)
- •9)Inability to swallow oral medication
- •10)Any malabsorption condition
- •11)Active infection
- •12)Breast feeding
- •13)Hypersensitivity to the active substance or to any of the excipients of any of the study medications
- •14)Any condition that in the opinion of the investigator could hamper the compliance with the study protocol.
- •Excluded therapies and medications, previous and concomitant:
- •15) Concomitant use of neurotoxic drugs
- •16)Concomitant use of compounds that have potentially positive effects towards symptoms of neuropathy (see section 6.1 for more details)
- •17)Time period between prior therapy and start of study treatment:
- •a)Prior radiotherapy: < 4 weeks
- •b)Prior flutamide or cyproterone acetate: < 4 weeks
- •c)Prior bicalutamide or nilutamide: < 6 weeks
- •18)Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
- •19)Major surgery less than 28 days prior to start of treatment
- •20)Prior treatment with epothilones
- •21)Use of any investigational drug within 4 weeks before start of study treatment
- •22)Alcohol abuse or abuse of other drugs with neurotoxic potential
研究者
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