Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Phase 2

Terminated

• Conditions: Metastatic Alveolar Soft Part Sarcoma
• Interventions: Drug: Pazopanib

• Registration Number: NCT02113826
• Lead Sponsor: Seoul National University Hospital

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 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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-15
• Primary Completion: 2016-09
• Status Verified: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pazopanib	Pazopanib	Pazopanib 800mg po qd until disease progression

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	One year	ORR based on RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	6 month
Overall survival	Two years
Number of Participants with Adverse Events	One year	Safety based on CTCAE v4.0

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of