check_circleStudy Completed

Ovarian neoplasms

Bayer Identifier:

91447

ClinicalTrials.gov Identifier:

NCT00246688

EudraCT Number:

2005-000635-15

EU CT Number:

Not Available
Efficacy and safety study of ZK219477 in patients with recurrent ovarian cancer

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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

Trial summary

Enrollment Goal
63
Trial Dates
November 2005 - June 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Northwood, HA6 2RN, United Kingdom
Completed
Surrey, SM2 5PT, United Kingdom
Completed
Newcastle upon Tyne, NE4 6BE, United Kingdom
Completed
Guildford, GU2 7XX, United Kingdom
Completed
Birmingham, B18 7QH, United Kingdom
Completed
Manchester, M20 4BX, United Kingdom
Completed
Glasgow, G11 6NT, United Kingdom
Completed
Cardiff, CF14 7TB, United Kingdom
Completed
Leeds, LS9 7TF, United Kingdom
Completed
London, NW1 2TG, United Kingdom
Terminated
Belfast, BT9 7AB, United Kingdom
Completed
Derby, DE1 2QY, United Kingdom
Terminated
Leicester, LE1 5WW, United Kingdom
Completed
Hull, HU8 9HE, United Kingdom
Terminated
ANGERS, 49933, France
Terminated
Caen, 14076, France
Terminated
Strasbourg, 67085, France
Terminated
Lille, 59020, France

Primary Outcome

  • Proportion of responders
    date_rangeTime Frame:
    18 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Duration of response
    date_rangeTime Frame:
    up to 1 year after LPLTV
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    Safety Issue:
    No
  • Time to disease progression
    date_rangeTime Frame:
    up to 1 year after LPLTV
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    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 30 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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

Additional Information

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