Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Lung Cancer, Small Cell

Treatments: Drug: Topotecan

Study type: Observational

Funder types: Industry

Identifiers

NCT01037023

113946

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

92 participants in 1 patient group

Patients administrated Topotecan

Description:

There is only one group. This group includes patients administrated Topotecan

Treatment:

Drug: Topotecan