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Clinical trial of LOXO-305 compared to a Bruton's tyrosine kinase inhibitor in patients with mantle cell lymphoma
THIS CLINICAL TRIAL IS BEING CONDUCTED TO TEST THE EFFICACY AND SAFETY OF AN INVESTIGATIONAL TREATMENT CALLED LOXO-305.LOXO-305 IS A CLINICAL (OR EXPERIMENTAL) INVESTIGATIONAL DRUG (INVESTIGATIONAL) THAT MAY TREAT CERTAIN TYPES OF CANCER SUCH AS LEUKEMIA AND LYMPHOMAS, INCLUDING MANTLE CELL LYMPHOMA (MCL). THESE TYPES OF CANCERS DEPEND ON, OR ARE "ADDICTED TO" A CANCER-GENERATING PROTEIN CALLED "BTK". LOXO-305 IS A "BTK INHIBITOR" DESIGNED TO BLOCK BOTH NORMAL AND MUTATED FORMS OF BTK IN THESE CANCERS. THESE CANCERS ARE ALSO TREATED WITH DRUGS SUCH AS IBRUTINIB, ACALABRUTINIB AND ZANUBRUTINIB, WHICH ARE APPROVED BY THE US FOOD AND DRUG ADMINISTRATION (FDA) AND OTHER HEALTH AUTHORITIES AROUND THE WORLD, ALTHOUGH ACALABRUTINIB AND ZANUBRUTINIB ARE NOT YET MARKETED IN SPAIN.
Technical Summary
- PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF LOXO-305 COMPARED TO AN INVESTIGATOR'S CHOICE BRUTON'S TYROSINE KINASE (BTK) INHIBITOR IN PATIENTS WITH PREVIOUSLY TREATED AND UNTREATED MANTLE CELL LYMPHOMA WITH BTK INHIBITORS (BRUIN MCL-321)
- Code EudraCT: 2020-004553-72
- Protocol number: LOXO-BTK-20019
- Promoter: Loxo Oncology, Inc.
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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