Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Sponsor
Seoul National University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02113826
Collaborator
Seoul National University Bundang Hospital (Other), Asan Medical Center (Other), Samsung Medical Center (Other), Severance Hospital (Other)
6
1
1
43
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Pazopanib in Patients With Metastatic Alveolar Soft Part Sarcoma
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pazopanib

Pazopanib 800mg po qd until disease progression

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

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (ORR) [One year]

    ORR based on RECIST v1.1

Secondary Outcome Measures

  1. Number of Participants with Adverse Events [One year]

    Safety based on CTCAE v4.0

  2. Progression-free survival [6 month]

  3. Overall survival [Two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • Seoul National University Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tae Min Kim, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02113826
Other Study ID Numbers:
  • 200240
First Posted:
Apr 15, 2014
Last Update Posted:
Nov 6, 2017
Last Verified:
Nov 1, 2017
Keywords provided by Tae Min Kim, MD, PhD, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 6, 2017