Back to resultsRegulatory Hycamtin(Oral) PMS (Hycamtin PMS)
Primary Purpose
Lung Cancer, Small Cell
Status
Completed
Phase
Locations
Korea, Republic of
Study Type
Observational
Intervention
Topotecan
Sponsored by
About this trial
This is an observational trial for Lung Cancer, Small Cell focused on measuring PMS (post-marketing surveillance), Topotecan
Eligibility Criteria
All subjects must satisfy the following criteria.
- Subject who is under the indication to the prescribing information of oral Hycamtin.
- Subject who is treated with oral Hycamtin according to the judgement of her or his investigator.
All subjects must not satisfy the following criteria.
• Subject who is under the contraindication to the prescribing information of oral Hycamtin.
As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Arm Label
Patients administrated Topotecan
Arm Description
There is only one group. This group includes patients administrated Topotecan
Outcomes
Primary Outcome Measures
Occurrence of adverse events after Topotecan administration
Secondary Outcome Measures
Occurrence of unexpected adverse event or adverse drug reaction
Occurrence of serious adverse event or adverse drug reation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01037023
Brief Title
Regulatory Hycamtin(Oral) PMS
Acronym
Hycamtin PMS
Official Title
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of HYCAMTIN Administered in Korean Patients According to the Prescribing Information
Study Type
Observational
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information
Detailed Description
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information
Topotecan will be administered as described the prescribing information or by physician's decision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Small Cell
Keywords
PMS (post-marketing surveillance), Topotecan
7. Study Design
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients administrated Topotecan
Arm Description
There is only one group. This group includes patients administrated Topotecan
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
patients administrated Topotecan according to the prescribing information
Primary Outcome Measure Information:
Title
Occurrence of adverse events after Topotecan administration
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Occurrence of unexpected adverse event or adverse drug reaction
Time Frame
9 months
Title
Occurrence of serious adverse event or adverse drug reation
Time Frame
9 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
All subjects must satisfy the following criteria.
Subject who is under the indication to the prescribing information of oral Hycamtin.
Subject who is treated with oral Hycamtin according to the judgement of her or his investigator.
All subjects must not satisfy the following criteria.
• Subject who is under the contraindication to the prescribing information of oral Hycamtin.
As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea.
Study Population Description
Patients administrated Topotecan at the site
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Regulatory Hycamtin(Oral) PMS
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