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Brief Title: A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
Official Title: A Phase 1/2 Study of Oral Selpercatinib (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)
Study ID: NCT03157128
Brief Summary: This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Detailed Description: This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive solid tumors, MTC, and other tumors with RET activation. The trial will be conducted in 2 parts: Phase 1 (dose escalation - completed) and phase 2 (dose expansion). Participants with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies, or no standard or available curative therapy exists, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy. A dose of 160 milligrams (mg) twice a day (BID) has been selected as the recommended phase 2 dose (RP2D). Approximately 875 participants with advanced solid tumors harboring a RET gene alteration in tumor and/or blood will be enrolled to one of seven phase 2 cohorts: * Cohort 1: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy (open) * Cohort 2: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for treatment naïve participants (open) * Cohort 3: Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy (closed) * Cohort 4: Advanced RET-mutant MTC participants who are treatment naïve (closed) * Cohort 5: Advanced RET-altered solid tumor for participants other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors (e.g. pheochromocytoma) otherwise ineligible for cohorts 1-4. See details in inclusion/exclusion criteria (open) * Cohort 6: Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval (closed) * Cohort 7: RET fusion positive early-stage non-small cell lung cancer (NSCLC) participants who are candidates for definitive surgery. Participants will receive selpercatinib in a neoadjuvant and adjuvant setting. Participants will be followed for disease recurrence for up to 5 years from the date of surgery (closed)
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic of Scottsdale, Scottsdale, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
University of California - San Diego, La Jolla, California, United States
UCLA Medical Center, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Irvine Medical Center, Orange, California, United States
UCSF Medical Center at Mission Bay, San Francisco, California, United States
Kaiser Permanente, Santa Clara, California, United States
Kaiser Permanente Medical Center, Vallejo, California, United States
Sarah Cannon Research Institute at HealthOne, Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Johns Hopkins University, Washington, District of Columbia, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Memorial Hospital Pembroke, Pembroke, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Chicago Medicine-Comprehensive Cancer Center, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
START Midwest, Grand Rapids, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University Medical School, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU Langone, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
USO-Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
University of Wisconsin-Madison Hospital and Health Clinic, Madison, Wisconsin, United States
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
BC Cancer Vancouver, Vancouver, British Columbia, Canada
Rigshospitalet, Copenhagen, København Ø, Denmark
Hôpital Européen Georges Pompidou, Paris, Cedex 15, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, , France
Centre Leon Berard, Lyon Cedex 08, , France
APHM Hôpital de la Timone, Marseille, , France
Institut du Cancer de Montpellier - Val d'aurelle, Montpellier Cedex 5, , France
Gustave Roussy, Villejuif Cedex, , France
Universitätsklinikum Würzburg A. ö. R., Würzburg, Bayern, Germany
Universitätsklinikum Köln, Köln, Nordrhein-Westfalen, Germany
Prince of Wales Hospital, Hong Kong, Shatin, New Territories, Hong Kong
Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
Shaare Zedek Medical Center, Jerusalem, Yerushalayim, Israel
Soroka Medical Center - Pediatric Outpatient Clinic, Beer-Sheva, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Istituto Nazionale dei Tumori, Milano, Lombardie, Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kindai University Hospital, Osaka Sayama-shi, Osaka, Japan
Tominaga Hospital, Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research, Koto, Tokyo, Japan
Tottori University Hospital, Yonago, Tottori, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka City General Hospital, Osaka, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
National Cancer Centre Singapore, Singapore, , Singapore
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Madrid Norte Sanchinarro, Madrid, , Spain
Kantonsspital Luzern, Luzern 16, Luzern, Switzerland
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR