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

Daiichi Sankyo

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Cancer; Advanced Cancer

Treatments: Drug: T-DXd

Study type: Interventional

Funder types: Industry

Identifiers

NCT06174987

2023-506330-73-00 (Other Identifier)

ROMast-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

T-DXd

Experimental group

Description:

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.

Treatment:

Drug: T-DXd