Trial Condition(s):
Efficacy and safety study of ZK219477 in patients with recurrent ovarian cancer
91447
Not Available
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.
- 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
- 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
Locations | Status | |
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Locations Investigative Site Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Surrey, United Kingdom, SM2 5PT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle upon Tyne, United Kingdom, NE4 6BE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guildford, United Kingdom, GU2 7XX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B18 7QH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glasgow, United Kingdom, G11 6NT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cardiff, United Kingdom, CF14 7TB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, NW1 2TG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Belfast, United Kingdom, BT9 7AB | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Derby, United Kingdom, DE1 2QY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leicester, United Kingdom, LE1 5WW | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hull, United Kingdom, HU8 9HE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANGERS, France, 49933 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Caen, France, 14076 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Strasbourg, France, 67085 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lille, France, 59020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2