Pazopanib for Metastatic Alveolar Soft Part Sarcoma

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Samsung Medical Center; Seoul National University Bundang Hospital; Severance Hospital

Criteria

Key Inclusion Criteria:

• Histologically confirmed diagnosis of alveolar soft part sarcoma harboring TFE3 fusion at stage IV or at relapse

• Age ≥ 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Measurable lesion defined by RECIST v1.1

• Chemo-naïve or prior chemotherapies

• Adequate organ function

Exclusion Criteria:

• Prior malignancies

• Active CNS disease

• High-risk for gastrointestinal bleeding

• Significant cardiovascular disease

• Uncontrolled hypertension

• Bleeding diathesis