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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174987
• Other study ID #: ROMast-001
• Secondary ID: 2023-506330-73-0
• Status: Recruiting
• Phase: Phase 3
• Start date: January 5, 2024
• Est. completion date: August 3, 2026

Study information

• Verified date: May 2024
• Source: Daiichi Sankyo
• Contact: Daiichi Sankyo Contact for Clinical Trial Information
• Phone: 908-992-6400
• Email: CTRinfo[@]dsi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 3, 2026
• Est. primary completion date: August 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• T-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

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Bedford Park
Australia	Monash Medical Center	Melbourne
Belgium	Grand Hôpital de Charleroi	Charleroi
France	Institut Gustave Roussy	Villejuif
Italy	Ospedale San Raffaele	Milano
Italy	Istituto Nazionale Tumori Fondazione G. Pascale	Napoli
Japan	National Cancer Center Hospital	Chuo city
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Jongno-gu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari Dexeus	Distrito De Les Corts
Spain	ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet de Llobregat
Spain	Hospital Ruber Internacional	Madrid
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Royal Surrey County Hospital	Guildford
United States	Duke University - Trent Center	Durham	North Carolina
United States	Miami Cancer Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo	AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Italy,  Japan,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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