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NCT04181333 Clinical Trial

Safety and Efficacy of Trastuzumab BS

Gastric Cancer Clinical Trial

Official title:
TRASTUZUMAB BS for Intravenous Infusion 60 mg [Pfizer], TRASTUZUMAB BS for Intravenous Infusion 150 mg [Pfizer] General Investigation (Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04181333
Other study ID # B3271007
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 9, 2023
Est. completion date September 8, 2025

Study information
Verified date March 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To confirm the safety and efficacy of this drug under the actual use

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date September 8, 2025
Est. primary completion date September 8, 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility Inclusion Criteria: - Patients with unresectable advanced/recurrent gastric cancer who are confirmed to have HER2 overexpression and started treatment with this drug* - Patients who receive this drug* for the first time after this drug* is launched * Not including the biological product, HERCEPTIN, and biosimilars of HERCEPTIN other than this drug Exclusion Criteria: - not specified in this study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TRASTUZUMAB BS
Regimen A or regimen B is used for HER2-overexpressing breast cancer. RegimenB is used for HER2-overexpressing unresectable advanced or recurrent gastric cancer in combination with other anti tumor agent(s). Regimen A: The recommended dose for trastuzumab (genetical recombination) [Trastuzumab Biosimilar 3] in adult patients is 4 mg/kg (weight) at initial dose and 2 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every week. Regimen B: The recommended dose for trastuzumab (genetical recombination) [Trastuzumab Biosimilar 3] in adult patients is 8 mg/kg (weight) at initial dose and 6 mg/kg after the second dose, in both of them, by IV drip infusion over 90 minutes once daily every 3 weeks. If the initial dose is well tolerated, the dosing time after the second dose can be shortened up to 30 minutes.

Locations
Country Name City State
Japan Pfizer Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse drug reactions in this surveillance 24 weeks
Secondary Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1. 24 Weeks
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