Master Rollover Study

JRCT ID: jRCT2031230379

Registered date:04/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: solid tumors
• Date of first enrollment: 22/12/2023
• Target sample size: 1
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,China,Japan,France,Japan,Italy,Japan,Korea,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Trastuzumab deruxtecan will be administered on Day 1 of a 21-day cycle intravenously at the same dose as the last dose the subject received in the parent study.

Outcome(s)

• Primary Outcome: TEAEs leading to study drug discontinuation and/or dose reduction, treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects 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 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 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.
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.

Inclusion Criteria in the sub-protocol:
Subjects must meet all of the following criteria to be eligible for enrollment into the study:
1. 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

Exclude criteria

Subjects who meet any of the following criteria will be disqualified from entering the study:
1. Subjects 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. 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.

Exclusion Criteria in the sub-protocol:
Subjects who meet any of the following criteria will be disqualified from entering the study:
1. Subjects with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
2. 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

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Secondary Sponsor: AstraZeneca
• Secondary ID(s): NCT06174987