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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

This is a Phase II, open-label, single-arm, multicentre, study in China
assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent

Study of T-DXd Monotherapy in Patients with HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma who have Received 2 or More Prior Regimens

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NCT ID

Patient Level Data

Therapeutic Area

Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Research Site

A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients with HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received
2 or More Prior Regimens (DESTINY-Gastric06)

Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.

Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1

PFS is defined as time from date of enrolment until progression per RECIST 1.1 as assessed by ICR or death due to any cause. PFS will be evaluated based on ICR and on investigator assessment.

DCR is defined as the percentage of participants who have a confirmed CR/PR or SD(without subsequent anticancer therapy) after date of enrolment.DCR will be evaluated based on ICR and on investigator assessment.

DoR is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. DoR will be evaluated based on ICR and on investigator assessment.

OS is defined as time from date of enrolment until the date of death due to any cause

Tumour size change will be evaluated based on ICR and investigator assessment.

Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd.

Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody.

Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for MAAA-1181a.

Presence of ADAs against T-DXd in serum during treatment (before infusion on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter) and at follow-up. Neutralising ADAs will also be assessed

Study of T-DXd Monotherapy in Patients with HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma who have Received 2 or More Prior Regimens - DG-06

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Verification:

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Documents available

Trial Results Summaries

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Contact