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Trial record 1 of 1 for:    alveolar soft part sarcoma | South Korea
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Pazopanib for Metastatic Alveolar Soft Part Sarcoma

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ClinicalTrials.gov Identifier: NCT02113826
Recruitment Status : Terminated (Low accrual rate)
First Posted : April 15, 2014
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Asan Medical Center
Samsung Medical Center
Severance Hospital
Information provided by (Responsible Party):
Tae Min Kim, Seoul National University Hospital

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
Metastatic Alveolar Soft Part Sarcoma Drug: Pazopanib 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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 : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: Pazopanib
Pazopanib 800mg po qd until disease progression
Drug: Pazopanib
Pazopanib 800mg qd daily for 4 weeks = 1 cycle




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: One year ]
    ORR based on RECIST v1.1


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: One year ]
    Safety based on CTCAE v4.0

  2. Progression-free survival [ Time Frame: 6 month ]
  3. Overall survival [ Time Frame: Two years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113826


Locations
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Korea, Republic of
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tae Min Kim, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02113826     History of Changes
Other Study ID Numbers: 200240
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by Tae Min Kim, Seoul National University Hospital:
Pazopanib
Alveolar soft part sarcoma
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Alveolar Soft Part
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue