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Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01099540
Recruitment Status : Completed
First Posted : April 7, 2010
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE April 6, 2010
First Posted Date  ICMJE April 7, 2010
Last Update Posted Date December 29, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2010)
response rate [ Time Frame: 1~2 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor
Official Title  ICMJE Phase II Study of Pazopanib Monotherapy in Patients With Unresectable, Metastatic Neuroendocrine Tumor
Brief Summary To determine the response rate of pazopanib when administered as monotherapy in patients with unresectable neuroendocrine tumor.
Detailed Description Not Provided
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 Neuroendocrine Tumor
Intervention  ICMJE Drug: Pazopanib
Pazopanib 800 mg qd daily
Study Arms  ICMJE Experimental: Pazopanib
Intervention: Drug: Pazopanib
Publications * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
37
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2010)
33
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT01099540
Other Study ID Numbers  ICMJE 2009-09-090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeeyun Lee, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date December 2015

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