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Metastatic Alveolar Soft Part SarcomaPhase 2NCT02113826

Pazopanib for Metastatic Alveolar Soft Part Sarcoma

A Phase 2 study testing Pazopanib in people with Metastatic Alveolar Soft Part Sarcoma, run by Seoul National University Hospital at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Alveolar Soft Part Sarcoma
What is being tested?
Pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSouth Korea
Study dates
Apr 2014to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Pazopanib
Keywords
Pazopanib, Alveolar soft part sarcoma
Medical subject headings
Sarcoma, Alveolar Soft Part

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Pazopanib 800mg qd daily for 4 weeks = 1 cycle

Study groups in NCT02113826
Study groupRoleWhat they receive
PazopanibExperimentalPazopanib 800mg po qd until disease progression
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    ORR based on RECIST v1.1

    Measured: One year

Secondary outcomes (3)

  1. Number of Participants with Adverse Events

    Safety based on CTCAE v4.0

    Measured: One year

  2. Progression-free survival

    Measured: 6 month

  3. Overall survival

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2016
  4. Study completionNov 2017

Why it stopped: Low accrual rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02113826
Sponsor's protocol ID
200240
Status last verified
Nov 2017
First submitted
9 Apr 2014
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30254189

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib in people with Metastatic Alveolar Soft Part Sarcoma, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low accrual rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02113826, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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