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Safety and Efficacy of Trastuzumab BS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181333
Recruitment Status : Not yet recruiting
First Posted : November 29, 2019
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
To confirm the safety and efficacy of this drug under the actual use

Condition or disease Intervention/treatment
Gastric Cancer Drug: TRASTUZUMAB BS

Study Design
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Study Type : Observational
Estimated 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)
Estimated Study Start Date : August 31, 2023
Estimated Primary Completion Date : September 8, 2025
Estimated Study Completion Date : September 8, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Trastuzumab

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. The incidence of adverse drug reactions in this surveillance [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1. [ Time Frame: 24 Weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100 patients
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181333


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04181333    
Other Study ID Numbers: B3271007
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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:
Recurrent HER2-Overexpressing Gastric Cancer
TRASTUZUMAB BS
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents