ISRCTN75009754
Completed
Phase 2
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 sites271 target enrollmentJanuary 30, 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bayer Schering Pharma AG (Germany)
- Enrollment
- 271
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24105751 [added 28/02/2019]
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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