Safety and Efficacy of Trastuzumab BS
Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04181333
Collaborator
(none)
150
35
Study Details
Study Description
Brief Summary
To confirm the safety and efficacy of this drug under the actual use
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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)
Anticipated Study Start Date
:
Nov 30, 2022
Anticipated Primary Completion Date
:
Oct 31, 2025
Anticipated Study Completion Date
:
Oct 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TRASTUZUMAB BS Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer patients injected TRASTUZUMAB BS |
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.
|
Outcome Measures
Primary Outcome Measures
- The incidence of adverse drug reactions in this surveillance [24 weeks]
Secondary Outcome Measures
- Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1. [24 Weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04181333
Other Study ID Numbers:
- B3271007
First Posted:
Nov 29, 2019
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Pfizer
Additional relevant MeSH terms: