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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00751205 |
This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of placebo (inactive) tablet in the prevention of Sagopilone induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3- weeks cycle. Up to 6 courses of treatment with Sagopilone will be given. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy and with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.
Condition | Intervention | Phase |
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Prostate Cancer Ovarian Cancer |
Drug: Sagopilone 16 mg/m2 i.v. and Acetyl-L-Carnitine (ALC) Placebo tid Drug: Sagopilone 16 mg/m2 i.v. and Placebo tid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | (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. |
Estimated Enrollment: | 140 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Sagopilone 16 mg/m2 i.v. and Acetyl-L-Carnitine (ALC) Placebo tid
Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Duration of treatment is up to 6 courses. In addition, subjects will receive 21 weeks ofAcetyl-L-Carnitine ( ALC) 1000mg tid. Subjects with HRPC will also receive Prednisone or Prednisolone 5mg bid, throughout the treatment with Sagopilone.
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Arm 2: Placebo Comparator |
Drug: Sagopilone 16 mg/m2 i.v. and Placebo tid
Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Duration of treatment is up to 6 courses. In addition, subjects will receive 21 weeks ofAcetyl-L-Carnitine (ALC) 1000mg tid. Subjects with HRPC will also receive Prednisone or Prednisolone 5mg bid, throughout the treatment with Sagopilone.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91695, EudraCT-2008-000879-26 |
Study First Received: | September 10, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00751205 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Peripheral Neuropathy Prostate Carcinoma Ovarian Carcinoma |
Prednisone Neurotoxicity Syndromes Genital Neoplasms, Male Prostatic Diseases Methylprednisolone Gonadal Disorders Urogenital Neoplasms Prednisolone acetate Ovarian Diseases Ovarian epithelial cancer Genital Diseases, Female Neuromuscular Diseases Methylprednisolone Hemisuccinate Endocrine Gland Neoplasms |
Acetylcarnitine Ovarian cancer Ovarian Neoplasms Neurotoxicity syndromes Genital Neoplasms, Female Endocrine System Diseases Methylprednisolone acetate Genital Diseases, Male Carcinoma Peripheral Nervous System Diseases Prednisolone Endocrinopathy Prostatic Neoplasms Carnitine |
Nootropic Agents Vitamin B Complex Growth Substances Nervous System Diseases Physiological Effects of Drugs Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Central Nervous System Agents |