NCT01147822

Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

A Study to Evaluate Efficacy and Safety of Pazopanib Versus Sunitinib for the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma - A Substudy to VEG108844

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, open label, parallel group, Phase II study to evaluate the efficacy and safety of pazopanib compared to sunitinib in Asian subjects with advanced renal cell carcinoma (RCC) who have not received prior systemic therapy for advanced or metastatic RCC.

Detailed description

Study VEG113078 is a substudy of Study VEG108844 (NCT00720941). Due to the projected limited enrollment of Asian participants into Study VEG108844, Study VEG113078 was designed to evaluate the efficacy and safety of pazopanib versus sunitinib for the treatment of Asian participants enrolled from selected Far-East Asian countries. The data for Study VEG113078 was pooled at the same time as the main study VEG108844 (NCT00720941). The subjects were centrally randomized in 1:1 ratio to receive open label study medication of either pazopanib 800mg to be administered once daily orally continuous dosing or sunitinib 50mg to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects were permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment continued until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Pazopanib	800 mg administered once daily orally continuous dosing
DRUG	Sunitinib	50 mg sunitinib to be administered in 6-week cycle: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment

Timeline

• Start date: 2010-05-19
• Primary completion: 2012-05-21
• Completion: 2021-09-03
• First posted: 2010-06-22
• Last updated: 2025-03-28
• Results posted: 2013-03-15

Locations

21 sites across 3 countries: China, South Korea, Taiwan