Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: March 27, 2014
Last verified: March 2014

December 10, 2009
March 27, 2014
November 2010
February 2015   (final data collection date for primary outcome measure)
Occurrence of adverse events after Topotecan administration [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
Occurrence of adverse events after Hycamtin administration [ Time Frame: 9months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01037023 on ClinicalTrials.gov Archive Site
Occurrence of unexpected or serious adverse event after Topotecan administration and effectiveness of Topotecan [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
Occurrence of unexpected or serious adverse event after Hycamtin administration and effectiveness of HYCAMTIN® [ Time Frame: 9months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Regulatory Hycamtin(Oral) PMS
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

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

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients administrated Topotecan at the site

Lung Cancer, Small Cell
Drug: Topotecan
patients administrated Topotecan according to the prescribing information
Patients administrated Topotecan
There is only one group. This group includes patients administrated Topotecan
Intervention: Drug: Topotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
780
February 2015
February 2015   (final data collection date for primary outcome measure)

Eligibility Criteria:

  • Subjects administered with Topotecan following the locally approved prescribing information
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
  • Subjects with no contraindication according to the prescribing information
Both
18 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Korea, Republic of
 
NCT01037023
113946
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP