A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

NCT06174987 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ROMast-0012023-506330-73-00
• Study Type: interventional
• Target: 50
• Locations: 12 countries
• Sites: 28

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 (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

Conditions

Advanced Cancer; Metastatic Cancer

Keywords

Advanced cancer; Metastatic cancer; T-DXd; DS8201a

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

T-DXd

EXPERIMENTAL

Participants who choose to continue treatment with T-DXd may be enrolled. Participants who were on the comparator arm in the parent study will be provided the option to access the drug through standard of care (SoC) or other available options. Participants will remain on their current dosage regimen of T-DXd as the last dose administered in the parent study, unless they experience an AE that requires dose reduction at the EOT of the parent study, in which case the starting dose in this study will be the next lower dose-level.

Drug: T-DXd

Interventions

T-DXd DRUG

T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens

Also known as: DS8201a

T-DXd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
• Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
• 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).

You may not qualify if:

• Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
• Participant 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

Sponsors & Collaborators

• Daiichi Sankyo: lead
• AstraZeneca: collaborator

Study Sites (28)

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

Duke University - Trent Center

Durham, North Carolina, 27710, United States

RECRUITING

Flinders Medical Center

Bedford Park, 5042, Australia

ACTIVE NOT RECRUITING

Monash Medical Center

Melbourne, 3168, Australia

WITHDRAWN

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

RECRUITING

Instituto Aericas

Rio de Janeiro, Brazil

NOT YET RECRUITING

A.C. Camargo Cancer Center

São Paulo, Brazil

NOT YET RECRUITING

IBCC Nucleo de Pequisa e Ensino

São Paulo, Brazil

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

ACTIVE NOT RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, 80131, Italy

WITHDRAWN

National Cancer Center Hospital

Chūō, 104-0045, Japan

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

National Cancer Center

Gyeonggi-do, 10408, South Korea

RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

WITHDRAWN

Seoul National University Hospital

Jongno-gu, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitari Dexeus

Distrito de Les Corts, 08028, Spain

NOT YET RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, 08908, Spain

RECRUITING

Hospital Ruber Internacional

Madrid, 28034, Spain

WITHDRAWN

National Cheng Kung University Hospital

Tainan, 704, Taiwan

WITHDRAWN

National Taiwan University Hospital

Taipei, 10002, Taiwan

WITHDRAWN

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

WITHDRAWN

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo@dsi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): January 17, 2028
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1); KR (7); ES (5); TW (2); GB (1); AU (2); BR (3); BE (1); US (2); FR (1); IT (2); IL (1)