Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: March 27, 2014
Last verified: March 2014
  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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse events after Topotecan administration [ Time Frame: 6weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of unexpected or serious adverse event after Topotecan administration and effectiveness of Topotecan [ Time Frame: 6weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: November 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 27, 2014
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 July 24, 2014