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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Sagopilone (BAY86-5302 , ZK219477)

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sagopilone, 0.5 h infusion

Sagopilone, 3 h infusion

Arm Description

Subjects received one infusion (for 0.5 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Subjects received one infusion (for 3 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Outcomes

Primary Outcome Measures

Proportion of responders

Secondary Outcome Measures

Duration of response

Time to disease progression

Number of participants with adverse events

Full Information

NCT ID

NCT00246688

First Posted

October 28, 2005

Last Updated

December 30, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00246688

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sagopilone, 0.5 h infusion

Arm Type

Experimental

Arm Description

Subjects received one infusion (for 0.5 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Arm Title

Sagopilone, 3 h infusion

Arm Type

Experimental

Arm Description

Subjects received one infusion (for 3 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks

Intervention Type

Drug

Intervention Name(s)

Sagopilone (BAY86-5302 , ZK219477)

Intervention Description

10.5 mg lyophilized sagopilone per vial

Primary Outcome Measure Information:

Title

Proportion of responders

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Duration of response

Time Frame

up to 1 year after LPLTV

Title

Time to disease progression

Time Frame

up to 1 year after LPLTV

Title

Number of participants with adverse events

Time Frame

Approximately 30 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

21372124

Citation

Rustin G, Reed N, Jayson GC, Ledermann JA, Adams M, Perren T, Poole C, Lind M, Persic M, Essapen S, Gore M, Calvert H, Stredder C, Wagner A, Giurescu M, Kaye S. A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer. Ann Oncol. 2011 Nov;22(11):2411-2416. doi: 10.1093/annonc/mdq780. Epub 2011 Mar 3.

Results Reference

result

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Ovarian Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial