Advanced Cancer, Metastatic Cancer
Conditions
Keywords
Advanced cancer, Metastatic cancer, T-DXd, DS8201a
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.
Detailed 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.
Interventions
DRUGT-DXd
T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens
Sponsors
Daiichi Sankyo
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Continued-access study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria to be eligible for enrollment into the study: 1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. 2. 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). 3. 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. 4. 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. 5. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout the Treatment Period in the compound-specific sub-protocol and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.
Exclusion criteria
Participants who meet any of the following criteria will be disqualified from entering the study: 1. Participants who permanently discontinued from the study drug in the parent study. 2. 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. 3. Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Baseline until disease progression, loss of clinical benefit, death, adverse event, pregnancy, withdrawal of consent, access to commercial supply, physician decision, or study closure, whichever occurs first, up to approximately 2 years 9 months |
Countries
Australia, Brazil, China, France, Hong Kong, Israel, Italy, Japan, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTDaiichi Sankyo Contact for Clinical Trial Information
STUDY_DIRECTORGlobal Clinical Leader
Daiichi Sankyo
Outcome results
None listed