Ovarian NeoplasmsPhase 2NCT00074867
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer
A Phase 2 study testing CP-547,632 in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Pfizer at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
- What is being tested?
- CP-547,632
- How many people
- 29 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Pfizer Investigational Site
Baltimore, Maryland, 21237
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Santa Monica, California, 90404
Canada2 sites
Pfizer Investigational Site
Hamilton, Ontario, L8V 5C2
Pfizer Investigational Site
Québec, Quebec, G1R 2J6
About this study
Official title: A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer
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.
- Being tested
- CP-547,632
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-547,632Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2003 (estimated)
- Study startOct 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074867
- Sponsor's protocol ID
- A3521003
- Status last verified
- Jul 2006
- First submitted
- 22 Dec 2003
- Last updated
- 7 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00074867
- Acronym / sponsor ID
- A3521003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Sep 2004
- First posted
- 24 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-547,632 | Drug | – |
Primary outcome
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.
1 secondary outcome
Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-547,632 in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Pfizer at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.