Clinical trial · Observational
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
NCT01037023CI-TRIAL-00017537Hycamtin PMScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Small Cell | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients administrated Topotecan
- description
- There is only one group. This group includes patients administrated Topotecan
- interventionNames
- Drug: Topotecan
Primary outcomes (1)
- measure
- Occurrence of adverse events after Topotecan administration
- timeFrame
- 9 months
Secondary outcomes (2)
- measure
- Occurrence of unexpected adverse event or adverse drug reaction
- timeFrame
- 9 months
- measure
- Occurrence of serious adverse event or adverse drug reation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.