Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
NCT ID: NCT06043427
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
168 participants
INTERVENTIONAL
2024-04-16
2026-06-30
Brief Summary
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Can the chance of gastroesophageal cancer growing or spreading be lowered by adding a drug called zanidatamab to the usual combination of drugs?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for gastroesophageal cancer
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Detailed Description
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This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding zanidatamab to the usual approach reduces the risk of cancer getting worse by at least 37% compared to the usual approach.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paclitaxel and Ramucriumab
Paclitaxel
80 mg/m²
Ramucirumab
8 mg/kg
Zanidatamab + Paclitaxel and Ramucirumab
Paclitaxel
80 mg/m²
Ramucirumab
8 mg/kg
Zanidatamab
Dose and schedule to be assigned at enrollment
Interventions
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Paclitaxel
80 mg/m²
Ramucirumab
8 mg/kg
Zanidatamab
Dose and schedule to be assigned at enrollment
Eligibility Criteria
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Inclusion Criteria
* Participants must have received and failed at least one prior trastuzumab-containing regimen in combination with platinum-based chemotherapy for treatment of locally advanced or metastatic disease. Failure is defined as demonstrated objective disease progression (radiologic) on the most recently administered HER2 targeting agent.
* Participants must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
* Participants must be considered a suitable candidate for, and able to receive chemotherapy for advanced disease with paclitaxel and ramucirumab.
* Participants must consent to the provision of samples of blood, serum and plasma in order that the specific correlative marker assays may be conducted.
* Participants must consent to provision of, and investigator(s) must confirm access to a representative formalin fixed paraffin embedded (FFPE) block of tumour tissue/ or a predetermined number of freshly cut slides of representative tumour tissue of adequate amount and quality in order that the central HER2 testing may be done
* Participants must be ≥ 18 years of age.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participants must have a life expectancy of at least 12 weeks at the time of study entry
* Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be done within 28 days prior to randomization
* Participants must have adequate cardiac function by ECHO or MUGA defined as EF ≥ 50%. This is to be performed within 4 weeks (preferred) but no more than 8 weeks prior to randomization
* Participants must have adequate normal organ and marrow function
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Participant must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method for the entire period of study treatment and for at least 7 months after discontinuing study therapy.
Exclusion Criteria
* Participants receiving therapy in a concurrent clinical study. Patients must agree not to participate in other clinical studies during their participation in this trial while on study treatment
* Participants with active or uncontrolled intercurrent illness
* Participants with human immunodeficiency virus infection (positive HIV 1/2 antibodies), active hepatitis B infection (positive HBV surface antigen (HBsAg)) or positive for hepatitis C (HCV) antibody may be considered for enrollment, if infection is adequately controlled in the opinion of the investigator.
* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy
* Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
* Any unresolved toxicity (CTCAE grade 2 or greater) from previous anti-cancer therapy which in the opinion of the investigator puts the participant at higher than expected risk during protocol treatment. However, participants with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational products in the Investigator's opinion may be included.
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Elena Elimova
Role: STUDY_CHAIR
University Health Network, Princess Margaret Cancer Centre, Toronto ON Canada
Locations
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Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
BCCA - Vancouver
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada
London Health Sciences Centre Research Inc.
London, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Centre Integre Universitaire De Sante Et De Services
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Hatim Karachiwala
Role: primary
Howard Lim
Role: primary
James T. Paul
Role: primary
Stephanie Snow
Role: primary
Dawn Ng
Role: primary
Oren Levine
Role: primary
Brooke Wilson
Role: primary
Anupam Batra
Role: primary
Daniel Breadner
Role: primary
Amin Kay
Role: primary
Rachel Goodwin
Role: primary
Michael Raphael
Role: primary
Suneil Khanna
Role: primary
Elena Elimova
Role: primary
Moustapha Tehfe
Role: primary
Setareh Samimi
Role: primary
Muhammad Salim
Role: primary
Adnan Zaidi
Role: primary
Other Identifiers
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GA4
Identifier Type: -
Identifier Source: org_study_id
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