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Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

This study is currently recruiting participants.
Verified January 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: February 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Lung Cancer, Small Cell
 Drug: Topotecan

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse events after Topotecan administration [ Time Frame: 9months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of unexpected or serious adverse event after Topotecan administration and effectiveness of Topotecan [ Time Frame: 9months ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: November 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients administrated Topotecan
There is only one group. This group includes patients administrated Topotecan
 Drug: Topotecan
patients administrated Topotecan 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients administrated Topotecan at the site

Criteria

Eligibility Criteria:

  • Subjects administered with Topotecan following the locally approved prescribing information
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
  • Subjects with no contraindication according to the prescribing information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037023

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 137-701
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01037023     History of Changes
Other Study ID Numbers: 113946
Study First Received: December 10, 2009
Last Updated: February 14, 2013
Health Authority: Korea: Korea Food & Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013