Double-blind, randomised phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy

Bayer Schering Pharma AG (Germany)0 个研究点目标入组 271 人开始时间: 2009年1月30日最近更新: 2019年6月17日

适应症

试验速览

•1. Males or females aged 18 years or over
•2. World Health Organization (WHO) performance status 0 to 1
•3. Epithelial ovarian, peritoneal cavity or fallopian tube cancer (except mucinous or clear cell tumours) or adenocarcinoma of the prostate (hormone-resistant prostate cancer [HRPC])
•4. At least one unidimensional measurable lesion (suitable for Response Evaluation Criteria in Solid Tumors [RECIST] evaluation) or for patients without measurable disease, CA 125 levels greater than or equal to two times the upper limit of normal (ULN) within 3 months and confirmed within 2 weeks prior to first infusion (ovarian cancer) or prostate specific antigen (PSA) value greater than or equal to 5 ng/mL (HRPC)
•5. For HRPC: progression of disease despite adequate androgen-inhibiting hormone therapy. For ovarian cancer: progression of disease or symptomatic relapse after previous therapy.
•6. No clinical residual neuropathy
•7. Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
•8. Adequate function of major organs and systems
•9. Survival expectation greater than or equal to 3 months
•10. Negative pregnancy test at enrolment (females of childbearing potential only)
•11. Written informed consent

•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 (some exceptions allowed)
•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 human immunodeficiency virus (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
•15. Concomitant use of neurotoxic drugs
•16. Concomitant use of compounds that have potentially positive effects towards symptoms of neuropathy
•17. Prior radiotherapy less than 4 weeks prior
•18. Prior flutamide of cyproterone acetate less than 4 weeks prior
•19. Prior bicalutamide or nilutamide less than 6 weeks prior
•20. Anticancer chemotherapy or immunotherapy during the study or within four weeks of study entry
•21. Major surgery less than 28 days prior to start of treatment
•22. Prior treatment with epothilones
•23. Use of any investigational drug within 4 weeks before start of study treatment

发起方

Bayer Schering Pharma AG (Germany)