Status:
COMPLETED
Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Ovarian
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a study to determine whether therapy with pazopanib is effective and safe in Asian women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has not progressed on...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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 2
- Able to swallow and retain oral medication.
- Adequate hematologic, hepatic, and renal system function as follows:
- Hematologic
- 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
- 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 randomization
- 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)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01227928
Start Date
September 1 2010
End Date
January 1 2014
Last Update
March 3 2015
Active Locations (15)
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1
GSK Investigational Site
Guangzhou, Guangdong, China
2
GSK Investigational Site
Nanjing, Jiangsu, China, 210009
3
GSK Investigational Site
Shenyang, Liaoning, China, 110022
4
GSK Investigational Site
Jinan, Shandong, China, 250012