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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01037023
Other study ID # 113946
Secondary ID
Status Completed
Phase N/A
First received December 10, 2009
Last updated April 14, 2015
Start date October 2010
Est. completion date November 2014

Study information

Verified date April 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Korea: Korea Food & Drug Administration
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Topotecan
patients administrated Topotecan according to the prescribing information

Locations

Country Name City State
Korea, Republic of GSK Investigational Site Seongnam-si, Gyeonggi-do
Korea, Republic of GSK Investigational Site Seoul

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of adverse events after Topotecan administration 9 months No
Secondary Occurrence of unexpected adverse event or adverse drug reaction 9 months No
Secondary Occurrence of serious adverse event or adverse drug reation 9 months No
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