Pazopanib for Metastatic Alveolar Soft Part Sarcoma

A Phase II Trial of Pazopanib in Patients With Metastatic Alveolar Soft Part Sarcoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02113826

Enrollment

Registered

2014-04-15

Start date

2014-04-30

Completion date

2017-11-30

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Alveolar Soft Part Sarcoma

Keywords

Pazopanib, Alveolar soft part sarcoma

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.

Interventions

DRUGPazopanib

Pazopanib 800mg qd daily for 4 weeks = 1 cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Overall response rate (ORR)	One year	ORR based on RECIST v1.1

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026