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Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Primary Purpose

Metastatic Alveolar Soft Part Sarcoma

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pazopanib
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Alveolar Soft Part Sarcoma focused on measuring Pazopanib, Alveolar soft part sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pazopanib

Arm Description

Pazopanib 800mg po qd until disease progression

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
ORR based on RECIST v1.1

Secondary Outcome Measures

Number of Participants with Adverse Events
Safety based on CTCAE v4.0
Progression-free survival
Overall survival

Full Information

First Posted
April 9, 2014
Last Updated
November 3, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Asan Medical Center, Samsung Medical Center, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02113826
Brief Title
Pazopanib for Metastatic Alveolar Soft Part Sarcoma
Official Title
A Phase II Trial of Pazopanib in Patients With Metastatic Alveolar Soft Part Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Low accrual rate
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Asan Medical Center, Samsung Medical Center, Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Alveolar Soft Part Sarcoma
Keywords
Pazopanib, Alveolar soft part sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pazopanib
Arm Type
Experimental
Arm Description
Pazopanib 800mg po qd until disease progression
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Intervention Description
Pazopanib 800mg qd daily for 4 weeks = 1 cycle
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR based on RECIST v1.1
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Safety based on CTCAE v4.0
Time Frame
One year
Title
Progression-free survival
Time Frame
6 month
Title
Overall survival
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30254189
Citation
Kim M, Kim TM, Keam B, Kim YJ, Paeng JC, Moon KC, Kim DW, Heo DS. A Phase II Trial of Pazopanib in Patients with Metastatic Alveolar Soft Part Sarcoma. Oncologist. 2019 Jan;24(1):20-e29. doi: 10.1634/theoncologist.2018-0464. Epub 2018 Sep 25.
Results Reference
derived

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Pazopanib for Metastatic Alveolar Soft Part Sarcoma

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