Managed Access Program (MAP)* to Provide Access to Asciminibfor Patients With CML in Chronic Phase
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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: NCT04360005 |
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Expanded Access Status :
Available
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Tracking Information | |||||||||
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| First Submitted Date | April 21, 2020 | ||||||||
| First Posted Date | April 24, 2020 | ||||||||
| Last Update Posted Date | April 24, 2020 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Managed Access Program (MAP)* to Provide Access to Asciminibfor Patients With CML in Chronic Phase | ||||||||
| Brief Summary | This program provides access to asciminib for patients with CML in chronic phase, with or without documented T315I mutation, without comparable or satisfactory alternative therapy to treat the disease | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Expanded Access | ||||||||
| Intervention | Drug: Asciminib
Asciminib 20 or 40 mg strength tablets will be administered orally twice-daily, without food
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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 | Not Provided | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT04360005 | ||||||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Study Sponsor | Novartis Pharmaceuticals | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Novartis | ||||||||
| Verification Date | April 2020 | ||||||||