Last updated: 11/03/2018 15:52:09
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Regulatory Hycamtin(Oral) PMSHycamtin PMS

GSK study ID
113946
See study documents
Clinicaltrials.gov ID
NCT01037023
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of adverse events after Topotecan administration

Timeframe: 9 months

Secondary outcomes:

Occurrence of unexpected adverse event or adverse drug reaction

Timeframe: 9 months

Occurrence of serious adverse event or adverse drug reation

Timeframe: 9 months

Interventions:
Drug: Topotecan
Enrollment:
92
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
May 2010 to November 2014
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • All subjects must satisfy the following criteria.
  • Subject who is under the indication to the prescribing information of oral Hycamtin.
Inclusion and exclusion criteria
Inclusion 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 location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Seongnam-si, Gyeonggi-do, South Korea, 463-707
Status
Study Complete
Contact us
Location
GSK Investigational Site
Seoul, South Korea, 137-701
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2014-23-11

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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