NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000052965

Registered date:01/12/2023

General drug use-results surveillance of Phesgo for combination subcutaneous injection MA and IN - Unresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy -

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnresectable advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy
Date of first enrollment2023/12/01
Target sample size100
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeMain items 1)Site information: Name of site, name of department, date of CRF entry, name of physician who entered the CRF 2)Patient characteristics: Patient's initials, gender, pregnancy, identification number within a site, age at the start of treatment, reason for use (HER2 overexpression/gene amplification test), height, weight, performance status (ECOG PS), treatment line, site of cancer, primary lesion, site of metastasis, complication, medical history, switching from pertuzumab/trastuzumab combination therapy to this drug 3)History of prior treatment: Drug therapy, surgery/radiotherapy 4)Administration status: Dose of this drug per administration, date of administration, premedication, status at entry of CRF 5)Concomitant therapy: radiotherapy 6)Adverse events: Name of adverse event or abnormal test value, date of onset, worst grade, seriousness, treatment, outcome, date of outcome, causal relationship (this drug, others)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaNone

Related Information

Contact

public contact
Name Ayako Murayama
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan 103-8324
Telephone 03-3281-6611
E-mail murayamaayk@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co. Ltd. Safety Science Dept.
scientific contact
Name Shinya Takemoto
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan
Telephone 03-3273-0769
E-mail takemotosny@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co. Ltd. Safety Science Dept.