A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T-DXd.
- Who it may be relevant to
- Registry conditions: Advanced Cancer, Metastatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Brazil, France +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Overview
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).
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.
Interventions
- 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
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 7 centers
- Kyungpook National University Chilgok Hospital — Daegu
- National Cancer Center — Gyeonggi-do
- Seoul National University Bundang Hospital — Gyeonggi-do
- Seoul National University Hospital — Jongno-gu
- Severance Hospital, Yonsei University — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
Spain · 5 centers
- Complejo Hospitalario Universitario A Coruña — A Coruña
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Universitari Dexeus — Distrito de Les Corts
- ICO l'Hospitalet - Hospital Duran i Reynals — L'Hospitalet de Llobregat
- Hospital Ruber Internacional — Madrid
Brazil · 3 centers
- Instituto Aericas — Rio de Janeiro
- A.C. Camargo Cancer Center — São Paulo
- IBCC Nucleo de Pequisa e Ensino — São Paulo
United States · 2 centers
- Miami Cancer Institute — Miami
- Duke University - Trent Center — Durham
Australia · 2 centers
- Flinders Medical Center — Bedford Park
- Monash Medical Center — Melbourne
Italy · 2 centers
- Ospedale San Raffaele — Milan
- Istituto Nazionale Tumori Fondazione G. Pascale — Naples
Taiwan · 2 centers
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
Belgium · 1 center
- Grand Hôpital de Charleroi — Charleroi
France · 1 center
- Institut Gustave Roussy — Villejuif
Israel · 1 center
- Rabin Medical Center — Petah Tikva
Japan · 1 center
- National Cancer Center Hospital — Chūō
United Kingdom · 1 center
- Royal Surrey County Hospital — Guildford
Identifiers
NCT: NCT06174987 · ROMast-001 · 2023-506330-73-00