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Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01037023
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):

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
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 : October 2010
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort 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 [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Occurrence of unexpected adverse event or adverse drug reaction [ Time Frame: 9 months ]
  2. Occurrence of serious adverse event or adverse drug reation [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated Topotecan at the site
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037023


Locations
Korea, Republic of
GSK Investigational Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01037023     History of Changes
Other Study ID Numbers: 113946
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
PMS (post-marketing surveillance)
Topotecan

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents