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Completed

NCT Number: NCT01037023

Regulatory Hycamtin(Oral) PMS

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

Completed

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Key information

Conditions

Lung Cancer, Small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Seongnam-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topotecan

Drug

patients administrated Topotecan according to the prescribing information

Primary outcomes

  1. Occurrence of adverse events after Topotecan administration

    Time frame: 9 months

Secondary outcomes

  1. Occurrence of unexpected adverse event or adverse drug reaction

    Time frame: 9 months

  2. Occurrence of serious adverse event or adverse drug reation

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: Hycamtin PMS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2009
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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