Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04566393 |
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Expanded Access Status :
Available
First Posted : September 28, 2020
Last Update Posted : February 14, 2023
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Sponsor:
xCures
Collaborator:
Cancer Commons
Information provided by (Responsible Party):
xCures
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| Tracking Information | |||||
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| First Submitted Date | September 17, 2020 | ||||
| First Posted Date | September 28, 2020 | ||||
| Last Update Posted Date | February 14, 2023 | ||||
| Descriptive Information | |||||
| Brief Title | Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies | ||||
| Brief Summary | The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Expanded Access | ||||
| Expanded Access Type | Intermediate-size Population | ||||
| Intervention | Drug: Ulixertinib (BVD-523)
Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Expanded Access Status | Available | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04566393 | ||||
| Current Responsible Party | xCures | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | xCures | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators | Cancer Commons | ||||
| Investigators | Not Provided | ||||
| PRS Account | xCures | ||||
| Verification Date | November 2022 | ||||