EUCTR2008-000879-26-DE进行中（未招募）不适用
(REASON) 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
适应症
相关药物
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
- All
入选标准
- •All of the following criteria have to be met for inclusion of a patient into the study:
- •1) Histologically or cytologically proven
- •a) Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous cell tumors) or clear cell tumors that have a clear cell component of > 33% 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 4 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).
- •8) Males or females = 18 years of age
- •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
- •Hepatic: - Total bilirubin:normal
- •- AST/ALT: = 3 times the upper limit of normal (= 5 x upper limit of
- •normal for patients with liver involvement of their cancer)
- •Renal: - Creatinine: = 2 mg/dL
- •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
- 另有 6 项未显示
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 medications
- •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
- •17) Time period since 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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