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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Peritoneal Cancer Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pazopanib

800 mg GW786034 administered orally on a daily basis.

Group Type EXPERIMENTAL

GW786034

Intervention Type DRUG

800 mg GW786034 administered orally on a daily basis.

Interventions

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GW786034

800 mg GW786034 administered orally on a daily basis.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No