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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

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE April 15, 2014
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Overall response rate (ORR) [ Time Frame: One year ]
ORR based on RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02113826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • Number of Participants with Adverse Events [ Time Frame: One year ]
    Safety based on CTCAE v4.0
  • Progression-free survival [ Time Frame: 6 month ]
  • Overall survival [ Time Frame: Two years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pazopanib for Metastatic Alveolar Soft Part Sarcoma
Official Title  ICMJE A Phase II Trial of Pazopanib in Patients With Metastatic Alveolar Soft Part Sarcoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Alveolar Soft Part Sarcoma
Intervention  ICMJE Drug: Pazopanib
Pazopanib 800mg qd daily for 4 weeks = 1 cycle
Study Arms  ICMJE Experimental: Pazopanib
Pazopanib 800mg po qd until disease progression
Intervention: Drug: Pazopanib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 22, 2016)
6
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
19
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02113826
Other Study ID Numbers  ICMJE 200240
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tae Min Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Severance Hospital
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP