NCT00113789

Brief Summary

This trial will provide data on the safety and efficacy of pegfilgrastim, in terms of duration of grade 4 neutropenia, when administered on the last day or the day after a multi-day, myelosuppressive chemotherapy regimen for ovarian cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_2 ovarian-cancer

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2005

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

1.5 years

First QC Date

June 10, 2005

Last Update Submit

February 12, 2009

Conditions

Ovarian Cancer

Keywords

ovarian cancertopotecanneutropeniaNeulasta®

Outcome Measures

Primary Outcomes (1)

  • Duration of Grade 4 Neutropenia

    During treatment

Study Arms (2)

Pegfilgrastim

ACTIVE COMPARATOR
Other: PI Discretion

Placebo

PLACEBO COMPARATOR
Other: PI Discretion

Interventions

PI DiscretionOTHER

PI Discretion

PegfilgrastimPlacebo

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsNeutropenia

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 DisordersAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2005

First Posted

June 13, 2005

Study Start

October 1, 2003

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

February 13, 2009

Record last verified: 2009-02