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

NCT ID: NCT03906331

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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N/A for expanded access

Conditions

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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

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Selpercatinib

Open-label expanded access

Intervention Type DRUG

Other Intervention Names

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LOXO-292 LY3527723

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Cancer Treatment Centers of America

Goodyear, Arizona, United States

Site Status

Mayo Clinic of Scottsdale

Scottsdale, Arizona, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

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Kaiser Permanente

Oakland, California, United States

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Irvine Medical Center

Orange, California, United States

Site Status

University of California - San Diego

San Diego, California, United States

Site Status

Univ of California San Francisco

San Francisco, California, United States

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Kaiser Permanente

Santa Clara, California, United States

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Kaiser Permanente Medical Center

Vallejo, California, United States

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Memorial Cancer Institute

Hollywood, Florida, United States

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Mayo Clinic in Florida

Jacksonville, Florida, United States

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Florida Hospital

Orlando, Florida, United States

Site Status

Tallahassee Memorial Cancer Center

Tallahassee, Florida, United States

Site Status

University Cancer and Blood Center

Athens, Georgia, United States

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Emory University

Atlanta, Georgia, United States

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University of Chicago Medicine-Comprehensive Cancer Center

Chicago, Illinois, United States

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Cancer Treatment Centers of America

Zion, Illinois, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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University of Michigan

Ann Arbor, Michigan, United States

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START Midwest

Grand Rapids, Michigan, United States

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Mayo Clinic

Rochester, Minnesota, United States

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Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

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Ohio State University Medical Center

Columbus, Ohio, United States

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Cancer Treatment Centers of America

Tulsa, Oklahoma, United States

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University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

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Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

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Oncology Consultants

Houston, Texas, United States

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

University of Wisconsin-Madison Hospital and Health Clinic

Madison, Wisconsin, United States

Site Status

NSW Health - Sydney Local Health District

Camperdown, New South Wales, Australia

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Royal North Shore Hospital

St Leonards, New South Wales, Australia

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Queensland Health - Metro North Hospital and Health Service

Chermside, Queensland, Australia

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Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status

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

Bordeaux, Aquitaine, France

Site Status

AP-HM

Marseille, , France

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Gustave Roussy

Villejuif, , France

Site Status

Universitätsklinikum Würzburg A. ö. R.

Würzburg, Bavaria, Germany

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Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Site Status

Charité Campus Virchow-Klinikum

Berlin, , Germany

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Prince of Wales Hospital

Hong Kong, Shatin, New Territories, Hong Kong

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Sheba Medical Center

Ramat Gan, Central District, Israel

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Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

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Soroka Medical Center - Pediatric Outpatient Clinic

Beersheba, , Israel

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Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

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Azienda Ospedaliero Universitaria Pisana

Pisa, PI, Italy

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National Cancer Center Hospital East

Kashiwa, Chiba, Japan

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

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Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

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National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

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Tottori University Hospital

Yonago, Tottori, Japan

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Osaka City General Hospital

Osaka, , Japan

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University of Auckland

Auckland, , New Zealand

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Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

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Centrum Onkologii Instytut im Marii Curie w Warszawie

Warsaw, , Poland

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National Cancer Centre Singapore

Singapore, Central Singapore, Singapore

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

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Hospital Madrid Norte Sanchinarro

Madrid, , Spain

Site Status

Kantonsspital Luzern

Lucerne, Canton of Lucerne, Switzerland

Site Status

Countries

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United States Australia France Germany Hong Kong Israel Italy Japan New Zealand Poland Singapore Spain Switzerland

References

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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.

Reference Type DERIVED
PMID: 36996322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36657661 (View on PubMed)

Other Identifiers

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Selpercatinib EAP

Identifier Type: OTHER

Identifier Source: secondary_id

J2G-OX-Y001

Identifier Type: OTHER

Identifier Source: secondary_id

17494

Identifier Type: -

Identifier Source: org_study_id

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