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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1022-011 | Other Identifier | MSD | |
| 2024-512442-41-00 | Registry Identifier | EU CT | |
| U1111-1305-0677 | Registry Identifier | UTN |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patritumab deruxtecan | Experimental | Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patritumab deruxtecan | Biological | Administered via intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase) | DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented. | Up to 21 days |
| Number of Participants with One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. | Up to approximately 44 months |
| Number of Participants who Discontinue Study Intervention Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented. | Up to approximately 44 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. | Up to approximately 44 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has one of the following cancers:
Has received prior therapy for the cancer.
Has recovered from any side effects due to previous cancer treatment
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Hematology Oncology Santa Monica ( Site 1205) | Active, not recruiting | Santa Monica | California | 90404 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Up to approximately 44 months |
| Progression Free Survival (PFS) | PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. | Up to approximately 44 months |
| Overall Survival (OS) | OS is the length of time from when the participant starts treatment until death from any cause. | Up to approximately 44 months |
| Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan | Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan. | At designated time points (up to ~44 months) |
| Trough Concentration (Ctrough) of Patritumab Deruxtecan | Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan. | At designated time points (up to ~44 months) |
| University of Colorado Cancer Center ( Site 1200) | Recruiting | Aurora | Colorado | 80045 | United States |
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| Sibley Memorial Hospital ( Site 1208) | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
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| University of Florida ( Site 1202) | Recruiting | Gainesville | Florida | 32610 | United States |
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| Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213) | Recruiting | Miami Beach | Florida | 33140 | United States |
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| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203) | Completed | Marietta | Georgia | 30060 | United States |
| University of Chicago Medical Center ( Site 1204) | Recruiting | Chicago | Illinois | 60637 | United States |
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| Renown Regional Medical Center ( Site 1221) | Recruiting | Reno | Nevada | 89502 | United States |
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| NYU Langone Hospital - Long Island ( Site 1230) | Completed | Mineola | New York | 11501 | United States |
| Perlmutter NYU Cancer Center ( Site 1212) | Completed | New York | New York | 10016 | United States |
| Scott & White Medical Center-Temple ( Site 1224) | Recruiting | Temple | Texas | 76508 | United States |
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| Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207) | Recruiting | Roanoke | Virginia | 24014 | United States |
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| University of Wisconsin ( Site 1210) | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Westmead Hospital ( Site 0100) | Recruiting | Sydney | New South Wales | 2145 | Australia |
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| Alfred Health ( Site 0102) | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Austin Health ( Site 0103) | Recruiting | Melbourne | Victoria | 3084 | Australia |
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| One Clinical Research ( Site 0104) | Recruiting | Mount Pleasant | Western Australia | 6009 | Australia |
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| QEII Health Sciences Centre - Victoria General Site ( Site 0200) | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
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| Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206) | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| McGill University Health Centre ( Site 0202) | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Fundacion Arturo Lopez Perez ( Site 0301) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Centro de Oncología de Precisión ( Site 0305) | Recruiting | Santiago | Region M. de Santiago | 7560908 | Chile |
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| Clínica UC San Carlos de Apoquindo ( Site 0302) | Recruiting | Santiago | Region M. de Santiago | 7620002 | Chile |
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| Bradfordhill ( Site 0300) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| The First Affiliated Hospital of Anhui Medical University ( Site 0405) | Recruiting | Hefei | Anhui | 230088 | China |
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| Fujian Provincial Cancer Hospital ( Site 0408) | Recruiting | Fuzhou | Fujian | 350014 | China |
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| Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412) | Recruiting | Xiamen | Fujian | 361015 | China |
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| Southern Medical University Nanfang Hospital ( Site 0413) | Recruiting | Fuzhou | Guangdong | 510515 | China |
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| The First Affiliated Hospital, Sun Yat-sen University ( Site 0404) | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411) | Recruiting | Nanning | Guangxi | 530200 | China |
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| Henan Cancer Hospital ( Site 0403) | Recruiting | Zhengzhou | Henan | 450008 | China |
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| Zhongshan Hospital,Fudan University ( Site 0400) | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| First Hospital of Shanxi Medical University ( Site 0409) | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| Hopital de la Croix Rousse ( Site 0502) | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69004 | France |
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| Hopital Beaujon ( Site 0500) | Recruiting | Clichy | Hauts-de-Seine | 92110 | France |
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| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501) | Recruiting | Rennes | Ille-et-Vilaine | 35042 | France |
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| Rambam Health Care Campus ( Site 0603) | Recruiting | Haifa | 3109601 | Israel |
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| Hadassah Medical Center ( Site 0602) | Recruiting | Jerusalem | 9112001 | Israel |
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| Sourasky Medical Center ( Site 0601) | Recruiting | Tel Aviv | 6423906 | Israel |
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| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700) | Recruiting | Milan | 20133 | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda ( Site 0701) | Recruiting | Milan | 20162 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702) | Recruiting | Roma | 00168 | Italy |
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| Harbour Cancer & Wellness ( Site 0800) | Recruiting | Auckland | 1023 | New Zealand |
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| Seoul National University Hospital ( Site 0900) | Recruiting | Seodaemun-gu | Seoul | 03080 | South Korea |
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| Severance Hospital, Yonsei University Health System ( Site 0903) | Recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center ( Site 0902) | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center ( Site 0901) | Recruiting | Seoul | 06351 | South Korea |
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| Hospital Central de Asturias ( Site 1001) | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
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| Hospital Universitari Vall d'Hebron ( Site 1000) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario Gregorio Maranon ( Site 1002) | Active, not recruiting | Madrid | 28007 | Spain |
| Hospital Clinico San Carlos... ( Site 1003) | Recruiting | Madrid | 28040 | Spain |
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| Hopitaux Universitaires de Geneve HUG. ( Site 1102) | Recruiting | Geneva | 1211 | Switzerland |
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| Universitaetsspital Zuerich ( Site 1105) | Recruiting | Zurich | 8091 | Switzerland |
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| National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502) | Recruiting | Tainan | 704 | Taiwan |
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| National Taiwan University Hospital ( Site 1500) | Recruiting | Taipei | 10002 | Taiwan |
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| Taipei Veterans General Hospital ( Site 1501) | Recruiting | Taipei | 112201 | Taiwan |
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| Faculty of Medicine Siriraj Hospital ( Site 1301) | Recruiting | Bangkoknoi | Bangkok | 10700 | Thailand |
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| Ramathibodi Hospital ( Site 1302) | Recruiting | Ratchathewi | Bangkok | 10400 | Thailand |
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| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400) | Recruiting | Yenimahalle | Ankara | 06200 | Turkey (Türkiye) |
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| Dokuz Eylul Universitesi Hastanesi ( Site 1402) | Recruiting | Balçova | İzmir | 35340 | Turkey (Türkiye) |
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| Adana City Hospital ( Site 1404) | Active, not recruiting | Adana | 01370 | Turkey (Türkiye) |
| Hacettepe Universite Hastaneleri ( Site 1401) | Active, not recruiting | Ankara | 06230 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000710748 | patritumab deruxtecan |
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