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Peritoneal CancerPhase 2NCT00281632

A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer

A Phase 2 study testing GW786034 in people with Peritoneal Cancer and Ovarian Cancer, run by GlaxoSmithKline at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment. Read more about this study

Who is it for?
Ages 21 years and older, women only
What is being tested?
GW786034
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
10 sitesin 3 countries
Study dates
Mar 2006to Oct 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
  • Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or oxaliplatin).
  • Has psychological, familial, sociological or geographical condition that does not permit compliance with the protocol.
  • Is on a specifically prohibited medication or requires these medications during treatment with GW786034.

Who cannot join

  • Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy with in the last 28 days and has not recovered from such prior therapy.
  • Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or higher).
  • Currently taking warfarin.
  • Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

United States5 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Bedford, Texas, 76022

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Fort Worth, Texas, 76104

Other trials in United States

Australia3 sites

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Melbourne, 3084

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

Singapore2 sites

  • GSK Investigational Site

    Singapore, 119074

  • GSK Investigational Site

    Singapore, 229899

Other trials in Singapore

About this study

Official title: This Study is a Non-randomized, Open-label, Multi-center Phase II Study of GW786034 to Evaluate the Administration of Oral GW786034 in Subjects With Ovarian Cancer.

This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.

Being tested
GW786034
Keywords
Pazopanib, Fallopian tube cancer, Ovarian epithelial cancer, Peritoneal cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW786034Drug

    800 mg GW786034 administered orally on a daily basis.

Study groups in NCT00281632
Study groupRoleWhat they receive
PazopanibExperimental800 mg GW786034 administered orally on a daily basis.
Receives: Drug: GW786034

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Biochemical Response (Cancer Antigen [CA-125])

    Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.

    Measured: Baseline to response (up to 3 years)

Secondary outcomes (18)

  1. Time to Biochemical Response (CA-125)

    Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.

    Measured: Baseline to response (up to 3 years)

  2. Duration of Biochemical Response (CA-125)

    Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.

    Measured: Baseline to response (up to 3 years)

  3. CA-125 Doubling Time Prior to and During Treatment With Pazopanib

    CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.

    Measured: Baseline to doubling of CA-125 (up to 3 years)

  4. Overall Response and Stable Disease (SD)

    Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.

    Measured: Baseline to response (up to 3 years)

  5. Median Progression-free Survival (PFS)

    Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.

    Measured: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)

  6. Overall Tumor Response

    Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.

    Measured: Baseline to response (up to 3 years)

  7. Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure

    Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.

    Measured: Baseline to response (up to 3 years)

  8. Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure

    Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.

    Measured: Baseline to response (up to 3 years)

  9. Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate

    Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.

    Measured: Baseline to response (up to 3 years)

  10. Mean Change From Baseline to Response in Albumin

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  11. Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  12. Mean Change From Baseline to Response in Amylase and Lipase

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  13. Mean Change From Baseline to Response in Total Bilirubin and Creatinine

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  14. Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  15. Mean Change From Baseline to Response in Thyroxine

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  16. Mean Change From Baseline to Response in Thyroid Stimulating Hormone

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  17. Mean Change From Baseline to Response in Hemoglobin and Hematocrit

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

  18. Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count

    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

    Measured: Baseline to response (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionApr 2008
  4. Study completionOct 2010

Resources

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281632
Sponsor's protocol ID
104450
Status last verified
Feb 2011
First submitted
23 Jan 2006
Last updated
17 Sep 2018
Expanded access
Available

Publications

  • Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010 Oct;119(1):32-7. doi: 10.1016/j.ygyno.2010.05.033. Epub 2010 Jun 27.

    PubMed 20584542

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW786034 in people with Peritoneal Cancer and Ovarian Cancer, run by GlaxoSmithKline at 10 sites in 3 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 4 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 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Australia, Singapore. 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?

Yes. Results are posted in the registry (first posted 4 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Best Biochemical Response (Cancer Antigen [CA-125]) (time frame: Baseline to response (up to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281632, which also lists 1 linked publication.

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 17 Sep 2018.

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