BridgeMD
A Master rollover study to provide continued access to, and assess, long term safety of the study drugs.
EU CTIS ID: 2023-506330-73-00
What this study is testing
To provide treatment to subjects continuing to derive clinical benefit from study drug-based therapy and continue to monitor long-term safety with ongoing treatment with study drug(s).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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). Note: subjects receiving post-progression treatment (for parent protocols that permit it) are eligible provided they are stable, as determined by radiological evaluation obtained a maximum of 6 weeks prior to screening for this study and following consultation with the medical monitor.
- 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. Methods considered as highly effective methods of contraception can be found in Protocol Section 10.4.1. If the subject 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. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone test
- 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.
- 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 (Appendix A) and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.
- Sign and date the informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements
You likely can't join if
- Subjects 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. Note: In countries where, according to local institutional requirements, it is not feasible to switch subjects to the commercial drug through prescription, even if fully reimbursed, subjects will be considered eligible to participate in the Rollover Study.
- Subjects with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
- Subject 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- Australia
- Japan
- Taiwan
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; Australia; Japan; Taiwan; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.