Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037023
First received: December 10, 2009
Last updated: April 14, 2015
Last verified: April 2015
  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
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: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of unexpected adverse event or adverse drug reaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse event or adverse drug reation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: October 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients administrated Topotecan at the site

Criteria

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.

  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

Locations
Korea, Republic of
GSK Investigational Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
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: April 14, 2015
Health Authority: Korea: Korea Food & Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2015