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 GSK Clinical Study Register is no longer maintained for this study.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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website