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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.


Phase 2
21 Years
N/A
Not Enrolling
Female
Malignant Tumor of Peritoneum, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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Trial Information

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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Baseline to response (up to 3 years)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Singapore: Health Sciences Authority

Study ID:

104450

NCT ID:

NCT00281632

Start Date:

March 2006

Completion Date:

October 2010

Related Keywords:

  • Malignant Tumor of Peritoneum
  • Ovarian Cancer
  • Neoplasms, Ovarian
  • Fallopian Tube Cancer
  • Pazopanib
  • Fallopian tube cancer
  • Ovarian epithelial cancer
  • Peritoneal cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405