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

StatusRecruiting

PhasePhase 3

Started2024-01-05

Record status

This record was last updated October 15, 2025 (before its estimated August 3, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-10-10

Study Status v9

Completion date2026-08-03→2028-01-17

2025-04-09

Study Status, Contacts/Locations v8

Study sites25→28

2024-12-11

Study Status, Contacts/Locations v7

Study sitesdetails revised at 1 of 25 sites

2024-09-04

Study Status, Contacts/Locations v6

Study sites24→25

2024-07-15

Study Status, Contacts/Locations v5

Study sitesdetails revised at 1 of 24 sites

Show 4 earlier versions

2024-06-26

Study Status, Contacts/Locations v4

Study sitesdetails revised at 3 of 24 sites

2024-05-17

Study Status, Contacts/Locations v3

Study sitesdetails revised at 5 of 24 sites

2024-05-01

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2024-03-31→confirmed 2024-01-05

Study sites27→24

2024-02-27

Study Status v1

Start date2023-12-31→2024-03-31

2023-12-08

Original filing

Daiichi Sankyo

69 trials monitored

See 8 trials at risk

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).

Trial Details

NCT Number	NCT06174987
Lead Sponsor	Daiichi Sankyo Collaborators: AstraZeneca
Conditions	Advanced Cancer, Metastatic Cancer
Enrollment	50 participants
Start Date	2024-01-05
Primary Completion	2026-08-03 (estimated)
Study Completion	2028-01-17 (estimated)
Updated on ClinicalTrials.gov	2025-10-15