NCT01037023

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4.1 years

First QC Date

December 10, 2009

Last Update Submit

April 14, 2015

Conditions

Lung Cancer, Small Cell

Keywords

PMS (post-marketing surveillance)Topotecan

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events after Topotecan administration

    9 months

Secondary Outcomes (2)

  • Occurrence of unexpected adverse event or adverse drug reaction

    9 months

  • Occurrence of serious adverse event or adverse drug reation

    9 months

Study Arms (1)

Patients administrated Topotecan

There is only one group. This group includes patients administrated Topotecan

Drug: Topotecan

Interventions

TopotecanDRUG

patients administrated Topotecan according to the prescribing information

Patients administrated Topotecan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients administrated Topotecan at the site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 21, 2009

Study Start

October 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

KR(2)