Study on Selpercatinib (LOXO-292) for Advanced Solid Tumors, RET Fusion-Positive Tumors, and Medullary Thyroid Cancer
Sponsor: Loxo Oncology, Inc.
ClinicalTrials ID:NCT03157128
This clinical trial is testing the safety and effectiveness of a new drug, Selpercatinib (LOXO-292), for treating advanced solid tumors, including those with specific genetic changes called RET fusions, and medullary thyroid cancer.
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Program Overview
This study is designed to test a new drug called Selpercatinib (LOXO-292) in people with advanced solid tumors, including those with RET fusion-positive tumors and medullary thyroid cancer. The trial aims to see if the drug is safe and how well it works in shrinking tumors. Participants will take the drug orally, and the study will be conducted in two parts: Phase 1, which has already been completed, and Phase 2, which is ongoing. The study will include about 875 participants with specific genetic changes in their tumors.
Description
This clinical trial is exploring the use of Selpercatinib (LOXO-292) for treating advanced solid tumors, including those with RET fusion-positive tumors and medullary thyroid cancer. The study is divided into two phases. Phase 1, which is already completed, focused on finding a safe dose of the drug. Phase 2 is currently enrolling participants to further test the drug's effectiveness. Participants are divided into different groups based on their type of cancer and previous treatments. The recommended dose for Phase 2 is 160 mg taken twice a day. The study aims to enroll about 875 participants with specific genetic changes in their tumors. Participants must have advanced cancer that has not responded to standard treatments or for which no standard treatment exists. The study will monitor the safety and effectiveness of Selpercatinib in shrinking tumors.
Eligibility Criteria
Inclusion Criteria
- Have advanced solid tumors that have not responded to standard treatments or for which no standard treatment exists.
- Have a specific genetic change called a RET gene alteration in their tumor or blood.
- Have measurable or non-measurable disease as determined by specific medical criteria.
- Be in good overall health with a performance status score of 0, 1, or 2.
- Have adequate blood, liver, and kidney function.
- Have a life expectancy of at least 3 months.
- For Phase 2, participants must have received prior standard therapy appropriate for their tumor type and stage of disease.
- Participants must have at least one measurable lesion that has not been previously treated with radiation.
- Participants with certain types of thyroid cancer or other tumors with neuroendocrine features may be eligible with prior approval.
Exclusion Criteria
- Have another known genetic driver of cancer in addition to the RET gene alteration.
- Have received prior treatment with a selective RET inhibitor, unless eligible for a specific group with prior approval.
- Have received any investigational or anti-cancer therapy within a certain time frame before starting the study drug.
- Have had major surgery or radiation therapy within a certain time frame before starting the study drug.
- Have unresolved side effects from previous treatments, except for certain conditions.
- Have active or untreated brain tumors or spinal cord compression.
- Have significant heart disease or a history of recent heart attack.
- Require treatment with certain medications that affect the liver enzyme CYP3A4.
- For certain groups, participants must not have received prior systemic therapy for their cancer.
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