Lung Cancer, Small CellHycamtin PMSNCT01037023
Regulatory Hycamtin(Oral) PMS
An observational study of Lung Cancer, Small Cell, run by GlaxoSmithKline at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Small Cell
- What is being tested?
- Topotecan
- How many people
- 92 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2010to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients administrated Topotecan at the site
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 locations and contacts
2 sites in 1 country.
South Korea2 sites
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 463-707
GSK Investigational Site
Seoul, 137-701
About this study
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
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
Read the 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.
- Conditions
- Lung Cancer, Small Cell
- Being tested
- Topotecan
- Keywords
- PMS (post-marketing surveillance), Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
patients administrated Topotecan according to the prescribing information
| Study group | Role | What they receive |
|---|---|---|
| Patients administrated Topotecan | There is only one group. This group includes patients administrated Topotecan Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events after Topotecan administration
Measured: 9 months
Secondary outcomes (2)
Occurrence of unexpected adverse event or adverse drug reaction
Measured: 9 months
Occurrence of serious adverse event or adverse drug reation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startOct 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037023
- Sponsor's protocol ID
- 113946
- Acronym
- Hycamtin PMS
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 2009
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01037023
- Acronym / sponsor ID
- Hycamtin PMS / 113946
- Conditions
- Lung Cancer, Small Cell
- Keywords
- PMS (post-marketing surveillance), Topotecan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients administrated Topotecan | – | Drug: TopotecanThere is only one group. This group includes patients administrated Topotecan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients administrated Topotecan at the site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topotecanpatients administrated Topotecan according to the prescribing information | Drug | Patients administrated Topotecan |
Primary outcome
Occurrence of adverse events after Topotecan administration
Time frame: 9 months
2 secondary outcomes
Occurrence of unexpected adverse event or adverse drug reaction
Time frame: 9 months
Occurrence of serious adverse event or adverse drug reation
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Small Cell, run by GlaxoSmithKline at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events after Topotecan administration (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015; AzTrials last refreshed its copy on 5 Nov 2026.