A Phase 1/2 Study of Oral LOXO-292 in Patients With Advanced Solid Tumors Including RET Fusion-Positive Solid Tumors Medullary Thyroid Cancer and Other Tumors With RET Activation (LIBRETTO-001)

Brief description of study

The purpose of this research study is to determine the safety of an investigational treatment called LOXO-292. LOXO-292 is an oral investigational drug that may treat cancer. Neither the FDA (U.S. Food and Drug Administration) nor any other health or regulatory authority in other countries have approved LOXO-292. This study will be the first time LOXO-292 will be taken by humans. The main purposes of this research study include the following: • To determine whether LOXO-292 is safe; • To identify which dose level of LOXO-292 should be studied in future studies; • To identify which of the dose levels used in this study is the highest tolerated dose or the dose that causes side effects that are too severe to continue treatment with LOXO-292; • To evaluate how the body absorbs and processes different doses of LOXO-292 by measuring the levels of LOXO-292 in the blood at different times (this is called pharmacokinetic (PK) testing); • To determine how well your cancer responds to treatment with LOXO-292; • To determine how long any benefits from treatment with LOXO-292 last.

Clinical Study Identifier: s18-01191
ClinicalTrials.gov Identifier: NCT03157128

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