Clinical Trial: Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: Overall response rate (ORR) [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of Participants with Adverse Events [ Time Frame: One year ]
  Safety based on CTCAE v4.0
• Progression-free survival [ Time Frame: 6 month ]
• Overall survival [ Time Frame: Two years ]

Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: April 9, 2014
Date Started: April 2014
Date Completion: November 2016
Last Updated: April 22, 2016
Last Verified: April 2016