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Completed

NCT Number: NCT00281632

A Phase II, Open-Label Study Evaluating the Effect Of 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.

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Key information

Conditions

Peritoneal Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Ovarian Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

GW786034

Drug

800 mg GW786034 administered orally on a daily basis.

Primary outcomes

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

    Time frame: Baseline to response (up to 3 years)

    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.

Secondary outcomes

  1. Time to Biochemical Response (CA-125)

    Time frame: Baseline to response (up to 3 years)

    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.

  2. Duration of Biochemical Response (CA-125)

    Time frame: Baseline to response (up to 3 years)

    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.

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

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

    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.

  4. Overall Response and Stable Disease (SD)

    Time frame: Baseline to response (up to 3 years)

    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.

  5. Median Progression-free Survival (PFS)

    Time frame: 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)

    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.

  6. Overall Tumor Response

    Time frame: Baseline to response (up to 3 years)

    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.

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

  10. Mean Change From Baseline to Response in Albumin

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

  15. Mean Change From Baseline to Response in Thyroxine

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

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

    Time frame: Baseline to response (up to 3 years)

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jan 25, 2006
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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