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临床试验/EUCTR2008-000879-26-ES
EUCTR2008-000879-26-ES进行中（未招募）1 期

Ensayo aleatorizado, doble ciego y de fase II para evaluar la seguridad y la eficacia de la acetil-L-carnitina en la prevención de la neuropatía periférica inducida por sagopilona. (REASON) (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

Bayer Schering Pharma AG0 个研究点目标入组 0 人开始时间: 2008年9月22日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
研究概览入排标准研究者记录与标识符相似试验

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

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
  • •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 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

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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