Back to resultsStudy of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor
Primary Purpose
Neuroendocrine Tumor
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pazopanib
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumor focused on measuring neuroendocrine tumor
Eligibility Criteria
Inclusion Criteria:
- low to intermediate grade neuroendocrine tumor not amenable to surgery or local therapy
Exclusion Criteria:
- poorly differentiated (high grade or anaplastic)/small cell, pheochromocytoma
Sites / Locations
- Samsung Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pazopanib
Arm Description
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01099540
First Posted
April 6, 2010
Last Updated
December 28, 2015
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01099540
Brief Title
Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor
Official Title
Phase II Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the response rate of pazopanib when administered as monotherapy in patients with unresectable neuroendocrine tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor
Keywords
neuroendocrine tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pazopanib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Intervention Description
Pazopanib 800 mg qd daily
Primary Outcome Measure Information:
Title
response rate
Time Frame
1~2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
low to intermediate grade neuroendocrine tumor not amenable to surgery or local therapy
Exclusion Criteria:
poorly differentiated (high grade or anaplastic)/small cell, pheochromocytoma
Facility Information:
Facility Name
Samsung Cancer Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23989950
Citation
Ahn HK, Choi JY, Kim KM, Kim H, Choi SH, Park SH, Park JO, Lim HY, Kang WK, Lee J, Park YS. Phase II study of pazopanib monotherapy in metastatic gastroenteropancreatic neuroendocrine tumours. Br J Cancer. 2013 Sep 17;109(6):1414-9. doi: 10.1038/bjc.2013.470. Epub 2013 Aug 29.
Results Reference
derived
Learn more about this trial
Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor
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