Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Seoul National University

Status and phase: Terminated; Phase 2

Conditions: Metastatic Alveolar Soft Part Sarcoma

Treatments: Drug: Pazopanib

Study type: Interventional

Funder types: Other

Identifiers

NCT02113826

200240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Pazopanib

Experimental group

Description:

Pazopanib 800mg po qd until disease progression

Treatment:

Drug: Pazopanib