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A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655

Phase 2
18 Years
Open (Enrolling)
Neoplasms, Ovarian

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Trial Information

A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655

This study is an extension study to the VEG110655 study. The parent study, VEG110655, was
designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression
free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal
cancer. These women will have obtained stable disease, a complete remission, or a partial
remission after debulking surgery and at least five cycles of chemotherapy
(taxane/platinum). This extension study will evaluate safety and efficacy outcomes of
pazopanib monotherapy and placebo in an Asian population with the same indication as the
parent study.

Inclusion Criteria:

- written informed consent

- At least 18 years old.

- Histologically confirmed, International Federation of Gynecology and Obstetrics
(FIGO) stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma
that was treated with surgical debulking and at least five cycles of platinum-taxane
doublet chemotherapy.

- Study randomization at least 3 weeks and not more than 12 weeks from the date of the
last chemotherapy dose, and all major toxicities from the previous chemotherapy must
have resolved.

- No evidence of disease progression

- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to

- Able to swallow and retain oral medication.

- Adequate hematologic, hepatic, and renal system function as follows:


- Absolute neutrophil count (ANC) at least 1.5 X 10^9/L

- Hemoglobin at least 9 g/dL (or 5.59 mmol/L)

- Platelets at least 100 X 10^9/L

- Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN

- Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic

- Total bilirubin up to 1.5 X ULN

- AST and ALT up to 2.5 X ULN Renal

- Serum creatinine up to 1.5 mg/dL

Or, if greater than 1.5 mg/dL:

Calculated creatinine clearance at least 50 mL/min Urine Protein

- Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram
determined by 24-hour urine protein analysis.

- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR
childbearing potential, and agrees to use adequate contraception.

Exclusion Criteria:

- Either (a) bulky disease, or (b) any residual disease which in the opinion of the
investigator will need imminent second-line therapy

- Synchronous primary endometrial carcinoma, or a past history of primary endometrial
carcinoma, are excluded unless certain conditions are met.

- Clinically significant gastrointestinal abnormalities

- Prolongation of corrected QT interval (QTc) > 480 msecs

- History of any one or more cardiovascular conditions within the past 6 months prior
to randomization

- Poorly controlled hypertension

- History of cerebrovascular accident (including transient ischemic attacks), pulmonary
embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to

- Major surgery (including interval debulking) or trauma within 28 days, or minor
surgical procedures within 7 days, prior to randomization, or has any non-healing
wound, fracture, or ulcer.

- Evidence of active bleeding or bleeding diathesis.

- Hemoptysis within 6 weeks prior to randomization.

- Endobronchial metastases.

- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection),
psychiatric, or other condition that could interfere with subject's safety, provision
of informed consent, or compliance to study procedures.

- Investigational or anti-VEGF anticancer therapy prior to study randomization.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib.

- Prior or concurrent invasive malignancies that currently or within the last 5 years
show/ed activity of disease (except ovarian, fallopian tube, or peritoneal cancer, or
concurrent endometrial cancer FIGO stages IA/B)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.

Outcome Time Frame:

From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

February 2015

Related Keywords:

  • Neoplasms, Ovarian
  • anti-angiogenesis
  • tyrosine kinase inhibitors
  • Fallopian Tube Cancer
  • pazopanib
  • ovarian cancer
  • Primary Peritoneal Carcinoma
  • primary peritoneal cancer
  • gynecologic cancer
  • Neoplasms
  • Ovarian Neoplasms