Sagopilone (BAY86-5302 , ZK219477)
Drug10.5 mg lyophilized sagopilone per vial
NCT Number: NCT00246688
The purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during, or in the last six months since a treatment of platinum-based chemotherapy. We also aim to look at the safety of the study drug and assess the impact of the infusion duration on tolerability.
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Notify Me18 year and older
Female
Interventional
Phase 2
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Females aged 18 or over - Cancer of any of the following types: -- epithelial ovarian cancer -- peritoneal cavity cancer -- fallopian tube cancer - Up to 2 previous chemotherapies; the most recent must have been a platinum- containing therapy - Progression of disease or symptomatic relapse during, or within 6 months of previous therapy - 4 weeks or more since prior radiotherapy or chemotherapy - 3 weeks or more since prior immunotherapy - Adequate recovery from previous surgery, radiotherapy, and chemotherapy ( excluding alopecia) - Survival expectation of 3 months or more Exclusion Criteria: - More than 2 previous chemotherapies - Previous treatment with epothilones - Use of any investigational drug within 4 weeks of start of study treatment or inadequate recovery from any toxic effects of such therapy - Previous radiation to the whole pelvis - Symptomatic brain metastases requiring whole-brain irradiation - Active infection - Any other malignancy except: -- Non-melanoma skin cancer -- Carcinoma in situ of cervix -- Malignancy with treatment 5 or more years ago without relapse - Mixed mesodermal tumor - Prior hormone therapy for any malignancy in the previous month - Women of childbearing potential
10.5 mg lyophilized sagopilone per vial
Time frame: 18 weeks
Time frame: up to 1 year after LPLTV
Time frame: up to 1 year after LPLTV
Time frame: Approximately 30 weeks
Bayer
Industry
Randomized, Multicenter, Prospective Two-arm, Open-label Phase II Study to Investigate the Efficacy and Safety of Two ZK219477 i.v. Infusions (3-hour Infusion of 16mg/m2 Versus 0.5-hour Infusion of 16 mg/m2) in Patients With Recurrent Ovarian Cancer Progressing During, or Within 6 Months of the End of Platinum-based Chemotherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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