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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02113826
Other study ID # 200240
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03233698 - Atezolizumab in Treating Patients With Newly Diagnosed and Metastatic Alveolar Soft Part Sarcoma That Cannot Be Removed by Surgery Phase 2
Not yet recruiting NCT06066138 - A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing Phase 1
Recruiting NCT05333458 - Testing Atezolizumab With or Without Selinexor in Patients >= 18 Years Old With Alveolar Soft Part Sarcoma, the Axiom Study Phase 2
Active, not recruiting NCT03141684 - Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People With Advanced Alveolar Soft Part Sarcoma Phase 2