None listed
Conditions
Interventions
Product Code: SH Y03757A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Sagopilone
CAS Number: 305841-29-6
Current Sponsor code: ZK 219477
Concentration unit: mg milligram(
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 N
Exclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: to demonstrate the superiority of ALC over placebo in the prevention of Sagopilone-induced peripheral neuropathy ;Secondary Objective: Secondary Objectives: • To assess the safety and efficacy of Sagopilone in combination with ALC • To assess the pharmacokinetics of Sagopilone in combination with ALC • To assess the pharmacogenomics of Sagopilone in combination with ALC ;Primary end point(s): Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of sagopilone treatment, based on Adverse Events. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed