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New treatment option for Gastroesophageal Adenocarcinoma
Official title Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
ClinicalTrials.gov ID: NCT06043427
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, being studied as a potential treatment for gastroesophageal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to answer the following question: 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or pathologically confirmed gastroesophageal adenocarcinoma (stomach, gastroesophageal junction or esophagus)...
- Participants must have received and failed at least one prior trastuzumab-containing regimen in combination with platinum-based chemotherapy for...
- 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...
You likely can't join if
- Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the...
- Participants receiving therapy in a concurrent clinical study. Patients must agree not to participate in other clinical studies during their...
- 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...
- 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
See the full eligibility criteria
- Participants must have histologically or pathologically confirmed gastroesophageal adenocarcinoma (stomach, gastroesophageal junction or esophagus) that is unresectable or metastatic and which must be HER2 positive as...
- 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...
- 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...
- 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...
- 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.
- Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Halifax, Nova Scotia, Canada
- Barrie, Ontario, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Kitchener, Ontario, Canada
- London, Ontario, Canada
- Oshawa, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Regina, Saskatchewan, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Barrie, Ontario, Canada; Hamilton, Ontario, Canada and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.