Clinical trial NCT03906331: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Official title: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
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
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-04-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.

Detailed description: N/A for expanded access

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic of Scottsdale
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Orange
country: United States
facility: Irvine Medical Center
state: California
city: San Diego
country: United States
facility: University of California - San Diego
state: California
city: San Francisco
country: United States
facility: Univ of California San Francisco
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine-Comprehensive Cancer Center
state: Illinois
city: Zion
country: United States
facility: Cancer Treatment Centers of America
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison Hospital and Health Clinic
state: Wisconsin
city: Camperdown
country: Australia
facility: NSW Health - Sydney Local Health District
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Queensland Health - Metro North Hospital and Health Service
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
state: Aquitaine
city: Marseille
country: France
facility: AP-HM
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg A. ö. R.
state: Bayern
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin, New Territories
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center - Pediatric Outpatient Clinic
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
state: Lombardie
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: PI
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Auckland
country: New Zealand
facility: University of Auckland
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im Marii Curie w Warszawie
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
state: Central Singapore
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Luzern 16
country: Switzerland
facility: Kantonsspital Luzern
state: Luzern
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References: