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Recruiting Phase 3 NCT06174987

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Phase 3 – large-scale trial before approval
Conditions: Advanced Cancer Metastatic Cancer

Sponsor: Daiichi Sankyo

trial.available_in: БГ
Overview
This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).
Description
This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.
Who can participate
Inclusion Criteria: * Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements. * Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. * No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). Exclusion Criteria: * Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria * Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
Locations 12
Australia (1)
Flinders Medical Center
Bedford Park
ACTIVE_NOT_RECRUITING
Belgium (1)
Grand Hôpital de Charleroi
Charleroi
Brazil (1)
Instituto Aericas
Rio de Janeiro
NOT_YET_RECRUITING
France (1)
Institut Gustave Roussy
Villejuif
Israel (1)
Rabin Medical Center
Petah Tikva
ACTIVE_NOT_RECRUITING
Italy (1)
Ospedale San Raffaele
Milan
Japan (1)
National Cancer Center Hospital
Chūō
South Korea (1)
Kyungpook National University Chilgok Hospital
Daegu
Spain (1)
Complejo Hospitalario Universitario A Coruña
A Coruña
Taiwan (1)
National Cheng Kung University Hospital
Tainan
WITHDRAWN
United Kingdom (1)
Royal Surrey County Hospital
Guildford
WITHDRAWN
United States (1)
Miami Cancer Institute
Miami , Florida
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.01.2024
Completion date
17.01.2028
Registry ID
NCT06174987
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.