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

February 27, 2024 updated by: Daiichi Sankyo

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daiichi Sankyo Contact for Clinical Trial Information
  • Phone Number: 908-992-6400
  • Email: CTRinfo@dsi.com

Study Locations

  • Australia
      • Bedford Park SA, Australia, 5042
        • Flinders Medical Center
      • Clayton VIC, Australia, 3168
        • Monash Medical Center
  • Belgium
      • Charleroi, Belgium
        • Grand Hôpital de Charleroi
  • China
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Harbin, China, 150040
        • Harbin Medical University Cancer Hospital
  • France
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
  • Japan
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpook National University Chilgok Hospital
      • Gyeonggi-do, Korea, Republic of
        • National Cancer Center
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University
      • Seoul, Korea, Republic of
        • Seoul National University Hospital - Site A
      • Seoul, Korea, Republic of
        • Seoul National University Hospital - Site B
  • Spain
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Barcelona, Spain, 08908
        • Ico L'Hospitalet - Hospital Duran I Reynals
      • Coruna, Spain, 15001
        • Complejo Hospitalario Universitario A Coruña
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University - Trent Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T-DXd

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

AstraZeneca

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2024

Primary Completion (Estimated)

August 3, 2026

Study Completion (Estimated)

August 3, 2026

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROMast-001
  • 2023-506330-73-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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