NCT00074867

Brief Summary

The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

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
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

November 7, 2006

Status Verified

July 1, 2006

First QC Date

December 22, 2003

Last Update Submit

November 6, 2006

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms

Outcome Measures

Primary Outcomes (1)

  • At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial.

Secondary Outcomes (1)

  • Given the outcome of the primary objective, analysis of secondary objectives were not formalized.

Interventions

CP-547,632DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerRecurrent or persistent elevated CA-125.
  • For the purpose of this study, elevated CA-125 is defined as a value of ≥40 U/ml on two separate consecutive determinations made ≥1 week apart.
  • CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into account.
  • No definitive disease or clinical and findings of small volume disease (\£1cm by spiral CT or \£2cm by conventional CT or clinical exam).

You may not qualify if:

  • No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide.
  • No prior consolidation therapy with cytotoxic agents for ovarian cancer.
  • Continuation of hormone replacement therapy is permitted.
  • No requirement for concomitant anticoagulant therapy.
  • Administration of low dose anticoagulants for maintenance of central venous access is permitted.No chronic oral or intravenous steroid use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21237, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

Hamilton, Ontario, L8V 5C2, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1R 2J6, Canada

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms

Interventions

3-(4-bromo-2,6-difluorobenzyloxy)-5-(3-(4-pyrrolidin-1-ylbutyl)ureido)isothiazole-4-carboxylic acid amide

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 DisordersAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesFallopian Tube Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2003

First Posted

December 24, 2003

Study Start

October 1, 2003

Study Completion

September 1, 2004

Last Updated

November 7, 2006

Record last verified: 2006-07

Locations

CA(2)US(7)