Hycamtin PMS: Regulatory Hycamtin(Oral) PMS

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01037023
• Collaborator: (none)
• Enrollment: 92
• Locations: 2
• Duration (Months): 49
• Patients Per Site: 46
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer, Small Cell	Drug: Topotecan

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 Design

• Study Type: Observational
• Actual Enrollment: 92 participants
• 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 Start Date: Oct 1, 2010
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Patients administrated Topotecan There is only one group. This group includes patients administrated Topotecan	Drug: Topotecan; patients administrated Topotecan according to the prescribing information

Outcome Measures

Primary Outcome Measures

1. Occurrence of adverse events after Topotecan administration [9 months]

Secondary Outcome Measures

1. Occurrence of unexpected adverse event or adverse drug reaction [9 months]

2. Occurrence of serious adverse event or adverse drug reation [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Seongnam-si, Gyeonggi-do		Korea, Republic of	463-707
2	GSK Investigational Site	Seoul		Korea, Republic of	137-701

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01037023
• Other Study ID Numbers: 113946
• First Posted: Dec 21, 2009
• Last Update Posted: Apr 15, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by GlaxoSmithKline: PMS (post-marketing surveillance); Topotecan
• Additional relevant MeSH terms: Small Cell Lung Carcinoma; Topotecan

Study Results

No Results Posted as of Apr 15, 2015