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Clinical trial to compare pralsetinib with standard treatment of RET-mutated medullary thyroid cancer

THIS RESEARCH STUDY (CLINICAL TRIAL) WILL EVALUATE THE SAFETY AND EFFECTS, POSITIVE OR NEGATIVE, OF PRALSETINIB COMPARED TO THE REFERENCE TREATMENT CHOSEN BY THE STUDY DOCTOR WITH VANDETANIB OR CABOZANTINIB TO DETERMINE IF IT IS AN EFFECTIVE WAY TO TREAT TNBC. PRALSETINIB WAS DESIGNED TO TREAT PATIENTS WITH CANCERS THAT HAVE ALTERATIONS IN THE RET GENE THAT CAN CAUSE THE TUMOR TO GROW. VARIATIONS IN RET (CALLED RET MUTATIONS) ARE FREQUENTLY DETECTED IN TNBC. PRELIMINARY DATA FROM CLINICAL STUDIES WITH PRALSETINIB HAVE SHOWN THAT THE DRUG IS EFFECTIVE IN PATIENTS WITH TNBC WITH AN ACCEPTABLE SAFETY PROFILE. THIS RESEARCH STUDY IS AN INTERNATIONAL, OPEN-LABEL, RANDOMIZED STUDY DESIGNED TO COMPARE THE EFFECTS OF AN INVESTIGATIONAL NEW DRUG CALLED PRALSETINIB ("STUDY DRUG") WITH THE EFFECT OF REFERENCE THERAPEUTIC OPTIONS FOR RET-MUTATED TNBC.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • RANDOMIZED, OPEN-LABEL PHASE III STUDY TO COMPARE PRALSETINIB WITH STANDARD TREATMENT OF RET-MUTATED MEDULLARY THYROID CANCER
  • Code EudraCT: 2020-005269-15
  • Protocol number: CO42865
  • Promoter: F. Hoffmann-La Roche Ltd.
  • Link to Clinical Trials

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