- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037023
Regulatory Hycamtin(Oral) PMS (Hycamtin 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
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- GSK Investigational Site
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Seoul, Korea, Republic of, 137-701
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients administrated Topotecan
There is only one group.
This group includes patients administrated Topotecan
|
patients administrated Topotecan according to the prescribing information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of adverse events after Topotecan administration
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of unexpected adverse event or adverse drug reaction
Time Frame: 9 months
|
9 months
|
Occurrence of serious adverse event or adverse drug reation
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Topotecan
Other Study ID Numbers
- 113946
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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