Pazopanib for Metastatic Alveolar Soft Part Sarcoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pazopanib Pazopanib 800mg po qd until disease progression |
Drug: Pazopanib
Pazopanib 800mg qd daily for 4 weeks = 1 cycle
|
Outcome Measures
Primary Outcome Measures
- Overall response rate (ORR) [One year]
ORR based on RECIST v1.1
Secondary Outcome Measures
- Number of Participants with Adverse Events [One year]
Safety based on CTCAE v4.0
- Progression-free survival [6 month]
- Overall survival [Two years]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Histologically confirmed diagnosis of alveolar soft part sarcoma harboring TFE3 fusion at stage IV or at relapse
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Age ≥ 18 years
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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Measurable lesion defined by RECIST v1.1
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Chemo-naïve or prior chemotherapies
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Adequate organ function
Exclusion Criteria:
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Prior malignancies
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Active CNS disease
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High-risk for gastrointestinal bleeding
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Significant cardiovascular disease
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Uncontrolled hypertension
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Bleeding diathesis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Seoul National University Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Samsung Medical Center
- Severance Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 200240