Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: July 24, 2014
Last verified: June 2014
History of Changes

December 10, 2009
July 24, 2014
November 2010
February 2015   (final data collection date for primary outcome measure)
Occurrence of adverse events after Topotecan administration [ Time Frame: 9 months ] [ 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 adverse event or adverse drug reaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse event or adverse drug reation [ Time Frame: 9 months ] [ 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)

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.
Both
Not Provided
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
June 2014

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