Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

NCT03906331 | Unknown

• 3 other identifiers: 17494Selpercatinib EAPJ2G-OX-Y001
• Study Type: expanded_access
• Target: N/A
• Locations: 13 countries
• Sites: 64

Brief Summary

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Conditions

Non Small Cell Lung Cancer; Medullary Thyroid Cancer; Colon Cancer; Breast Cancer; Pancreatic Cancer; Papillary Thyroid Cancer; Other Solid Tumors With Evidence of Activating RET Alteration

Interventions

Selpercatinib DRUG

Open-label expanded access

Also known as: LOXO-292, LY3527723

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib
• Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
• Have adequate organ function

You may not qualify if:

• Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
• Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (64)

Cancer Treatment Centers of America

Goodyear, Arizona, 85338, United States

Location

Mayo Clinic of Scottsdale

Scottsdale, Arizona, 85259, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-0269, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Kaiser Permanente

Oakland, California, 94612, United States

Location

Irvine Medical Center

Orange, California, 92868, United States

Location

University of California - San Diego

San Diego, California, 92103, United States

Location

Univ of California San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

Location

Memorial Cancer Institute

Hollywood, Florida, 33021, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Tallahassee Memorial Cancer Center

Tallahassee, Florida, 32308, United States

Location

University Cancer and Blood Center

Athens, Georgia, 30607, United States

Location

Emory University

Atlanta, Georgia, 30329-5102, United States

Location

University of Chicago Medicine-Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Cancer Treatment Centers of America

Zion, Illinois, 60099, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Cancer Treatment Centers of America

Tulsa, Oklahoma, 74133, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

University of Wisconsin-Madison Hospital and Health Clinic

Madison, Wisconsin, 53792-4108, United States

Location

NSW Health - Sydney Local Health District

Camperdown, New South Wales, 2050, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Queensland Health - Metro North Hospital and Health Service

Chermside, Queensland, 4032, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, 33076, France

Location

AP-HM

Marseille, 13005, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Würzburg A. ö. R.

Würzburg, Bavaria, 97080, Germany

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Prince of Wales Hospital

Hong Kong, Shatin, New Territories, 999077, Hong Kong

Location

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 9103102, Israel

Location

Soroka Medical Center - Pediatric Outpatient Clinic

Beersheba, 8410101, Israel

Location

Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, PI, 56124, Italy

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Tottori University Hospital

Yonago, Tottori, 683-8504, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

University of Auckland

Auckland, 91346, New Zealand

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Centrum Onkologii Instytut im Marii Curie w Warszawie

Warsaw, 02-034, Poland

Location

National Cancer Centre Singapore

Singapore, Central Singapore, 169610, Singapore

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 8035, Spain

Location

Hospital Madrid Norte Sanchinarro

Madrid, 28050, Spain

Location

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (2)

• Rotow J, Patel JD, Hanley MP, Yu H, Awad M, Goldman JW, Nechushtan H, Scheffler M, Kuo CS, Rajappa S, Harada G, Clifford S, Santucci A, Silva L, Tupper R, Oxnard GR, Kherani J, Drilon A. Osimertinib and Selpercatinib Efficacy, Safety, and Resistance in a Multicenter, Prospectively Treated Cohort of EGFR-Mutant and RET Fusion-Positive Lung Cancers. Clin Cancer Res. 2023 Aug 15;29(16):2979-2987. doi: 10.1158/1078-0432.CCR-22-2189.

  PMID: 36996322 DERIVED

• Murciano-Goroff YR, Falcon CJ, Lin ST, Chacko C, Grimaldi G, Liu D, Wilhelm C, Iasonos A, Drilon A. Central Nervous System Disease in Patients With RET Fusion-Positive NSCLC Treated With Selpercatinib. J Thorac Oncol. 2023 May;18(5):620-627. doi: 10.1016/j.jtho.2023.01.008. Epub 2023 Jan 16.

  PMID: 36657661 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Medullary; Colonic Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Thyroid Cancer, Papillary

Interventions

selpercatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma, Papillary; Thyroid Neoplasms; Head and Neck Neoplasms; Thyroid Diseases

Study Officials

• Contact Lilly at 1-800-LillyRx (1-800-545-5979)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Last Updated: January 17, 2025

Record last verified: 2024-12

Locations

JP (6); SG (1); FR (3); US (34); IT (2); HK (1); DE (3); AU (5); NZ (1); CH (1); PL (2); IL (3); ES (2)