Study of Pazopanib Monotherapy in Patients With Unresecta... | NCT01099540

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

NCT01099540

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Dec 29, 2015Estimated

Enrollment

37Actual

Phase

Phase 2

Conditions

Neuroendocrine Tumor

Interventions

Pazopanib

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2013Actual

First Submitted Date

Apr 6, 2010

First Submission Date that Met QC Criteria

Apr 6, 2010

First Posted Date

Apr 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2015

Last Update Posted Date

Dec 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the response rate of pazopanib when administered as monotherapy in patients with unresectable neuroendocrine tumor.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pazopanib	Experimental		Drug: Pazopanib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pazopanib	Drug	Pazopanib 800 mg qd daily	Pazopanib

Measure	Description	Time Frame
response rate		1~2 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Cancer Center		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23989950	Derived	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.

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms