Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

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 first-line chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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 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 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 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)