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Pazopanib for Metastatic Alveolar Soft Part Sarcoma

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Disease Information

Descriptive Information
Brief Title † Pazopanib for Metastatic Alveolar Soft Part Sarcoma
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 (
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
Study Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Overall response rate (ORR)
Secondary Outcome Measure † Number of Participants with Adverse Events
Condition † Metastatic Alveolar Soft Part Sarcoma
Intervention † DrugPazopanib
Study Arms / Comparison Groups Pazopanib Pazopanib 800mg po qd until disease progression
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 19
Start Date † April 2014
Completion Date March 2017
Primary Completion Date March 2016
Eligibility 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Tae Min Kim, MD, PhD, 82-2-2072-3559, gabriel9@snu.ac.kr
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT02113826
Organization ID 200240
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Seoul National University Hospital
Collaborators †† Seoul National University Bundang Hospital
Investigators † : ,
Information Provided By
Verification Date April 2014
First Received Date † April 9, 2014
Last Updated Date March 7, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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