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Spots Global Cancer Trial Database for A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

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Trial Identification

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

Interventions

LOXO-292

Study Description

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)

Keywords

LOXO-292
KIF5B-RET
M918T
CCDC6-RET
RET-PTC1
NCOA4-RET
RET-PTC
RET-PTC3
RET-PTC4
PRKAR1A-RET
RET-PTC2
GOLGA5-RET
RET-PTC5
ERC1-RET
KTN1-RET
RET-PTC8
HOOK3-RET
PCM1-RET
TRIM24-RET
RET-PTC6
TRIM27-RET
TRIM33-RET
RET-PTC7
AKAP13-RET
FKBP15-RET
SPECC1L-RET
TBL1XR1-RET
BCR-RET
FGRF1OP-RET
RFG8-RET
RET-PTC9
ACBD5-RET
MYH13-RET
CUX1-RET
KIAA1468-RET
FRMD4A-RET
SQSTM1-RET
AFAP1L2-RET
PPFIBP2-RET
EML4-RET
PARD3-RET
G533C
C609F
C609G
C609R
C609S
C609Y
C611F
C611G
C611S
C611Y
C611W
C618F
C618R
C618S
C620F
C620R
C620S
C630R
C630Y
D631Y
C634F
C634G
C634R
C634S
C634W
C634Y
K666E
E768D
L790F
V804L
V804M
A883F
S891A
R912P
CLIP1-RET
Y806C
RET fusion
RET alteration
RET mutation
RET rearrangement
RET translocation
Neoplasms by Site
Neoplasms
Non-Small Cell Lung Cancer
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Respiratory Tract Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Medullary Thyroid Cancer
Papillary Thyroid Cancer
Thyroid Diseases
Thyroid Neoplasms
Cancer of the Thyroid
Cancer of Thyroid
Neoplasms, Thyroid
Thyroid Ademona
Thyroid Cancer
Thyroid Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Thoracic Neoplasms
CNS tumor
Primary CNS tumor
Cancer of Colon
Cancer of the Colon
Colon Cancer
Colon Neoplasms
Colonic Cancer
Neoplasms, Colonic
Malignant tumor of Breast
Mammary Cancer
Mammary Carcinoma, Human
Mammary Neoplasm, Human
Neoplasms, Breast
Tumors, Breast
Human Mammary Carcinoma
Malignant Neoplasm of Breast
Breast Carcinoma
Breast Tumors
Cancer of the Breast
Breast Neoplasms
Breast Cancer
RET Inhibitor
MTC
NSCLC
selpercatinib
neo-adjuvant treatment in early stage NSCLC

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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