EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

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.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

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.

CSR Synopsis redacted

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

CTIS Number

EudraCT Number

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.

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Participants with Objective Response = 21

Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)

Complete response (confirmed after at least 4 weeks)

Partial response
(confirmed after at least 4 weeks)

Stable disease

Progression

Not evaluable

The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression

Best objective response rate by RECIST 1.1 based on independent central review (ICR)

PFS rate

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease
progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Progression-free survival (PFS)  based on independent central review (ICR)

3-month PFS rate

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Progression-free survival (PFS) rate at 3 months  based on independent central review (ICR)

6-month PFS rate

Progression-free survival (PFS) rate at 6 months  based on independent central review (ICR)

9-month PFS rate

Progression-free survival (PFS) rate at 9 months  based on independent central review (ICR)

12-month PFS rate

Progression-free survival (PFS) rate at 12 months  based on independent central review (ICR)

15-month PFS rate

Progression-free survival (PFS) rate at 15 months  based on independent central review (ICR)

18-month PFS rate

Progression-free survival (PFS) rate at 18 months  based on independent central review (ICR)

21-month PFS rate

Progression-free survival (PFS) rate at 21 months  based on independent central review (ICR)

Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD)

Disease Control Rate (DCR) based on independent central review (ICR)

Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD) for at least 11 weeks (ie 12 weeks - 1 week to allow for an early assessment within the assessment window)

Disease Control Rate (DCR) based on independent central review (ICR) at Week 12

DoR defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) or death in the absence of progression based on investigator assessments by using RECIST version 1.1

Duration of Response (DoR)  based on independent central review (ICR)

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

Overall survival (OS)  based on independent central review (ICR)

Best percentage change based on ICR is defined as the best change in target lesion tumour size from baseline (maximum reduction or minimum increase from baseline in the absence of a reduction)

Best percentage change in sum of diameters of Measurable tumours based on independent central review (ICR)

Overall Study

Global Clinical Lead

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSP redacted

SAP redacted

CSR Synopsis redacted

Trial Results Summaries

Contacts

Contact