NCT06174987 A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
| NCT ID | NCT06174987 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Daiichi Sankyo |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2026-08-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2024-01-05 with a primary completion date of 2026-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Global Clinical Leader
STUDY DIRECTOR
Daiichi Sankyo
Frequently Asked Questions
Who can join the NCT06174987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06174987 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT06174987 currently recruiting?
Yes, NCT06174987 is actively recruiting participants. Contact the research team at CTRinfo@dsi.com for enrollment information.
Where is the NCT06174987 trial being conducted?
This trial is being conducted at Miami, United States, Durham, United States, Bedford Park, Australia, Melbourne, Australia and 11 additional locations.
Who is sponsoring the NCT06174987 clinical trial?
NCT06174987 is sponsored by Daiichi Sankyo. The principal investigator is Global Clinical Leader at Daiichi Sankyo. The trial plans to enroll 50 participants.
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