NCT02113826

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2.4 years

First QC Date

April 9, 2014

Last Update Submit

November 3, 2017

Conditions

Metastatic Alveolar Soft Part Sarcoma

Keywords

PazopanibAlveolar soft part sarcoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    ORR based on RECIST v1.1

    One year

Secondary Outcomes (3)

  • Number of Participants with Adverse Events

    One year

  • Progression-free survival

    6 month

  • Overall survival

    Two years

Study Arms (1)

Pazopanib

EXPERIMENTAL

Pazopanib 800mg po qd until disease progression

Drug: Pazopanib

Interventions

PazopanibDRUG

Pazopanib 800mg qd daily for 4 weeks = 1 cycle

Pazopanib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior malignancies
  • Active CNS disease
  • High-risk for gastrointestinal bleeding
  • Significant cardiovascular disease
  • Uncontrolled hypertension
  • Bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30254189DERIVED

MeSH Terms

Conditions

Sarcoma, Alveolar Soft Part

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

November 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

KR(1)