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Monoclonal Antibodies

AZD0901 arm 1 for Gastroesophageal Junction Cancer

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).

Awards & highlights

Study Summary

This trial aims to compare the effectiveness and safety of AZD0901 with other treatment options for patients with advanced stomach or gastroesophageal junction cancer that has spread, and that expresses a specific protein

Who is the study for?

This trial is for adults with advanced or metastatic stomach or gastroesophageal junction cancer that expresses a protein called Claudin18.2, who have already tried at least one other treatment. Participants should not be receiving other cancer treatments and must have adequate organ function.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of AZD0901 against standard therapies chosen by the investigator, such as TAS-102, Docetaxel, Paclitaxel, Apatinib, Ramucirumab with Paclitaxel, or Irinotecan in patients with certain types of stomach cancers.See study design

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues like nausea, fatigue, hair loss (with some drugs), lowered blood cell counts leading to increased infection risk or bleeding problems. The exact side effects will depend on the specific therapy received.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS) for 3L+ participants

Progression Free Survival (PFS) in all randomized participants

Secondary outcome measures

Duration of Response (DoR) in all randomized participants

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs

ORR for 3L+ participants

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: AZD0901 arm 1Experimental Treatment1 Intervention

Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.

Group II: AZD0901 Arm 2Experimental Treatment1 Intervention

Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment.

Group III: Investigator's choice armActive Control6 Interventions

Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,086 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct settings is this research study being conducted?

"The research project is active at a total of 101 sites, with facilities in cities such as Kansas City, Portland, and Changsha among others. It is advisable to choose the nearest clinic for convenience and to reduce travel commitments upon enrollment."

Answered by AI

Which specific criteria determine the inclusion of individuals into this research study?

"Individuals aged between 18 and 130 diagnosed with gastric cancer are sought for this clinical investigation, aiming to recruit approximately 589 participants."

Answered by AI

Does this medical study enroll individuals who are aged 55 years or older?

"This investigation seeks individuals over 18 years old but under the age of 130 to participate."

Answered by AI

Is the enrollment process open for this medical study at present?

"Yes, the information on clinicaltrials.gov indicates that this trial is currently seeking volunteers. The trial was initially listed on March 4, 2024, and its most recent update was on March 28, 2024. A total of 589 participants are sought across a network of 101 sites."

Answered by AI

Has the first arm of the AZD0901 trial received approval from the Food and Drug Administration?

"According to our team at Power, the safety rating for arm 1 of AZD0901 is a 3 on the scale due to its Phase 3 status. This suggests that there exists some evidence supporting its effectiveness and multiple datasets affirming its safety profile."

Answered by AI

What is the total number of individuals currently under research in this clinical trial?

"Indeed, the details available on clinicaltrials.gov indicate that this investigation is actively seeking eligible participants. Initially shared with the public on March 4th, 2024, and most recently revised on March 28th, 2024, this study aims to enroll a total of 589 patients distributed across 101 medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

2024. "AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06346392.

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