NCT02113826

Pazopanib for Metastatic Alveolar Soft Part Sarcoma

A Phase II Trial of Pazopanib in Patients With Metastatic Alveolar Soft Part Sarcoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Alveolar soft part sarcoma (ASPS), a rare subset of STS (\<1%) harbors t(X;17)(p11;q25) translocation and produces resultant ASPL-TFE3 fusion protein. Due to its nature of high expression of angiogenic factors, sunitinib and cediranib produced overall response rates of 55% and 43%, respectively. However, the efficacy of pazopanib is unknown in metastatic ASPS.

Detailed description

Pazopanib, a multi-targeted anti-angiogenesis inhibitor significantly prolonged progression-free survival (PFS) in patients with metastatic soft-tissue sarcoma (STS) after failure to anthracycline-based regimen (pazopanib vs placebo, 4.6 vs 1.6 months, HR=0.31, 95% CI 0.24-0.40; P \< .0001). Regarding sunitinib (continuous daily dose of 37.5mg), after a median duration of 10 months, median OS and PFS were 19 months and 17 months, respectively in a small retrospective study (ASPS, N=9). With regard to cediranib, 6-month PFS was over 60%. In addition, randomized phase II trial of sunitinib vs cediranib with cross-over at disease progression was recently initiated (NCT01391962). However, the efficacy of pazopanib is unknown in metastatic ASPS.

Conditions

• Metastatic Alveolar Soft Part Sarcoma

Interventions

Type	Name	Description
DRUG	Pazopanib	Pazopanib 800mg qd daily for 4 weeks = 1 cycle

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-09-01
• Completion: 2017-11-01
• First posted: 2014-04-15
• Last updated: 2017-11-06

Locations

1 site across 1 country: South Korea