Regulatory Hycamtin(Oral) PMS

Lung Cancer, Small Cell Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037023
• Other study ID #: 113946
• 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

• Lung Cancer, Small Cell
• Small Cell Lung Carcinoma

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