Regulatory Hycamtin(Oral) PMS

Completed

• Conditions: Lung Cancer, Small Cell
• Interventions: Drug: Topotecan

• Registration Number: NCT01037023
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Study Start: 2010-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients administrated Topotecan	Topotecan	There is only one group. This group includes patients administrated Topotecan

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events after Topotecan administration	9 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of unexpected adverse event or adverse drug reaction	9 months
Occurrence of serious adverse event or adverse drug reation	9 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of