A Master rollover study to provide continued access to, and assess, long term safety of the study drugs.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Daiichi Sankyo Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Mar 2024 → ongoing

Decision date (initial)

2024-03-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Daiichi Sankyo, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

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).

Conditions and MedDRA coding

Advanced (unresectable or metastatic) human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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). 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.
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. 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
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 (Appendix A) and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.
6. 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

Exclusion criteria 5

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.
4. Subjects with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
5. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Daiichi Sankyo Inc.

Sponsor organisation

Daiichi Sankyo Inc.

Address

211 Mount Airy Road

City

Basking Ridge

Postcode

07920-2311

Country

United States

Scientific contact point

Organisation

Daiichi Sankyo Inc.

Contact name

Clinical Trial Office

Public contact point

Organisation

Daiichi Sankyo Inc.

Contact name

Clinical Trial Office

Third parties 3

Locations

4 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications