Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas : A Phase I Trial of Ulixertinib (BVD-523) and Hydroxychloroquine in Patients With Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas
This is an open-label Phase I basket trial designed to determine the phase 2 recommended dose of ulixertinib in combination hydroxychloroquine. The recommended phase 2 dose (RP2D) will be determined by using a standard 3+3 dose-escalation design with a minimum of 3 evaluable subjects accrued to dose level one and two. Should dose level one be deemed intolerable, enrollment will proceed at dose level 0. The RP2D will be affirmed according to the rules of the 3+3 dose-escalation scheme.
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 20. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 30, 2019, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 |
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| Study ID: |
NCT04145297 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000129011 |
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| 245 | 1 | 0 | |a Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas |b A Phase I Trial of Ulixertinib (BVD-523) and Hydroxychloroquine in Patients With Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas |
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| 520 | |a This is an open-label Phase I basket trial designed to determine the phase 2 recommended dose of ulixertinib in combination hydroxychloroquine. The recommended phase 2 dose (RP2D) will be determined by using a standard 3+3 dose-escalation design with a minimum of 3 evaluable subjects accrued to dose level one and two. Should dose level one be deemed intolerable, enrollment will proceed at dose level 0. The RP2D will be affirmed according to the rules of the 3+3 dose-escalation scheme | ||
| 650 | 2 | |a Adenocarcinoma | |
| 650 | 2 | |a Gastrointestinal Neoplasms | |
| 650 | 2 | |a Digestive System Neoplasms | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a Phase: Phase 1 | |
| 650 | 4 | |a 610 | |
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