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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506330-73-00 | Other Identifier | EU CTIS |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daiichi Sankyo Contact for Clinical Trial Information | Contact | 908-992-6400 | CTRinfo@dsi.com |
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute | Recruiting | Miami | Florida | 33176 | United States | |
| Duke University - Trent Center |
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/
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.
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.
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| Recruiting |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Flinders Medical Center | Active, not recruiting | Bedford Park | 5042 | Australia |
| Monash Medical Center | Withdrawn | Melbourne | 3168 | Australia |
| Grand Hôpital de Charleroi | Recruiting | Charleroi | 6000 | Belgium |
| Instituto Aericas | Not yet recruiting | Rio de Janeiro | Brazil |
| A.C. Camargo Cancer Center | Not yet recruiting | São Paulo | Brazil |
| IBCC Nucleo de Pequisa e Ensino | Not yet recruiting | São Paulo | Brazil |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Rabin Medical Center | Active, not recruiting | Petah Tikva | Israel |
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Withdrawn | Naples | 80131 | Italy |
| National Cancer Center Hospital | Recruiting | Chūō | 104-0045 | Japan |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | 41404 | South Korea |
| National Cancer Center | Recruiting | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Withdrawn | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Recruiting | Jongno-gu | 03080 | South Korea |
| Severance Hospital, Yonsei University | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Complejo Hospitalario Universitario A Coruña | Recruiting | A Coruña | 15006 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitari Dexeus | Not yet recruiting | Distrito de Les Corts | 08028 | Spain |
| ICO l'Hospitalet - Hospital Duran i Reynals | Recruiting | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital Ruber Internacional | Withdrawn | Madrid | 28034 | Spain |
| National Cheng Kung University Hospital | Withdrawn | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Withdrawn | Taipei | 10002 | Taiwan |
| Royal Surrey County Hospital | Withdrawn | Guildford | GU2 7XX | United Kingdom |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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