Prevention of sagopilone-induced neurotoxicity with acetyl-L-carnitine (ALC)

Phase 2

Completed

• Conditions: Cancer; Ovarian cancer; hormone-resistant prostate cancer; Malignant neoplams of specified sites

• Registration Number: ISRCTN75009754
• Lead Sponsor: Bayer Schering Pharma AG (Germany)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24105751 [added 28/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-30
• Study Completion: 2010-08-05
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 271

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)
11. Written informed consent

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified