Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00246688
First received: October 28, 2005
Last updated: February 25, 2009
Last verified: February 2009
  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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: Sagopilone (BAY86-5302, ZK219477)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of responders [ Time Frame: 18 weeks ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: up to 1 year after LPLTV ]
  • Time to disease progression [ Time Frame: up to 1 year after LPLTV ]

Enrollment: 68
Study Start Date: November 2005
Study Completion Date: June 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sagopilone (BAY86-5302, ZK219477)
16mg/m2 sagopilone given as 3-hr infusion
Experimental: Arm 2 Drug: Sagopilone (BAY86-5302, ZK219477)
16mg/m2 sagopilone given as 0,5-hr infusion

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246688

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00246688     History of Changes
Other Study ID Numbers: 91447, EudraCT No: 2005-000635-15, 307970
Study First Received: October 28, 2005
Last Updated: February 25, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 21, 2014