Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Metastatic Alveolar Soft Part Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02113826
• Other study ID #: 200240
• Status: Terminated
• Phase: Phase 2
• First received: April 9, 2014
• Last updated: November 3, 2017
• Start date: April 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Alveolar Soft Part Sarcoma
• Sarcoma
• Sarcoma, Alveolar Soft Part

Intervention

Drug:
• Pazopanib
Pazopanib 800mg qd daily for 4 weeks = 1 cycle

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	ORR based on RECIST v1.1	One year
Secondary	Number of Participants with Adverse Events	Safety based on CTCAE v4.0	One year
Secondary	Progression-free survival		6 month
Secondary	Overall survival		Two years