NCT00246688

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

October 28, 2005

Last Update Submit

December 30, 2015

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Proportion of responders

    18 weeks

Secondary Outcomes (3)

  • Duration of response

    up to 1 year after LPLTV

  • Time to disease progression

    up to 1 year after LPLTV

  • Number of participants with adverse events

    Approximately 30 weeks

Study Arms (2)

Sagopilone, 0.5 h infusion

EXPERIMENTAL

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

Drug: Sagopilone (BAY86-5302 , ZK219477)

Sagopilone, 3 h infusion

EXPERIMENTAL

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

Drug: Sagopilone (BAY86-5302 , ZK219477)

Interventions

Sagopilone (BAY86-5302 , ZK219477)DRUG

10.5 mg lyophilized sagopilone per vial

Sagopilone, 0.5 h infusionSagopilone, 3 h infusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21372124RESULT

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

sagopilone

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 31, 2015

Record last verified: 2015-12