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

NCT ID: NCT01227928

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-01-31

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 first-line chemotherapy.

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) 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.

Conditions

Neoplasms, Ovarian

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

pazopanib

experimental medication

Group Type: EXPERIMENTAL

Pazopanib

Intervention Type: DRUG

Pazopanib 800 mg daily for 24 months

placebo

placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

Placebo 800 mg daily for 24 months

Interventions

Pazopanib

Pazopanib 800 mg daily for 24 months

Intervention Type: DRUG

Placebo comparator

Placebo 800 mg daily for 24 months

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Guangzhou, Guangdong, China

GSK Investigational Site

Nanjing, Jiangsu, China

GSK Investigational Site

Shenyang, Liaoning, China

GSK Investigational Site

Jinan, Shandong, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Hong Kong, , Hong Kong

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

Countries

China; Hong Kong; South Korea; Taiwan

References

Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.

Reference Type: DERIVED

PMID: 26588236 (View on PubMed)

Other Identifiers

114012

Identifier Type: -

Identifier Source: org_study_id