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Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: Lapatinib (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.

Clinical Details

Official title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Study design: N/A

Primary outcome: The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with HER2 overexpressing inoperable or recurrent breast cancer

Exclusion Criteria:

- Patients with hypersensitivity to lapatinib or any components

- Pregnant women and women suspected of being pregnant

Locations and Contacts

Additional Information

Starting date: June 2009
Last updated: July 9, 2015

Page last updated: August 23, 2015

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