Phase 3: testing T-DXd for Advanced Cancer
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.
Official registry: https://clinicaltrials.gov/study/NCT06174987 · Daiichi Sankyo · enrollment listed as 75
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are T-DXd. The registry lists allocation as na. 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.
They plan to enroll about 75 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Interventions: T-DXd
Primary outcome (registry wording): Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Participants must meet all of the following criteria to be eligible for enrollment into the study:
- Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition
- No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s)
- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug
- a. If the participant is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug
- Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration
Who the registry excludes
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Participants who permanently discontinued from the study drug in the parent study
- Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject
- Local access to commercially available drug at no cost to the subject as permitted by local/country regulation
Public study contact (from the registry)
Daiichi Sankyo Contact for Clinical Trial Information
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
34 listed- Research Facility — Miami, Florida (active_not_recruiting)
- Research Facility — Durham, North Carolina (active_not_recruiting)
+ 32 sites outside the US on the same record
FAQ about this NCT record
Is NCT06174987 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06174987?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06174987?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary