Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Primary Purpose
Non Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer
Status
Available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Selpercatinib
Sponsored by
About this trial
This is an expanded access trial for Non Small Cell Lung Cancer
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
Sites / Locations
- Cancer Treatment Centers of America
- Mayo Clinic of Scottsdale
- City of Hope National Medical Center
- Irvine Medical Center
- University of California - San Diego
- Univ of California San Francisco
- Memorial Cancer Institute
- Mayo Clinic in Florida
- Florida Hospital
- Tallahassee Memorial Cancer Center
- University Cancer and Blood Center
- Emory University
- University of Chicago Medicine-Comprehensive Cancer Center
- Cancer Treatment Centers of America
- Dana-Farber Cancer Institute
- University of Michigan
- START Midwest
- Mayo Clinic
- Memorial Sloan Kettering Cancer Center
- Cleveland Clinic Foundation
- Ohio State University Medical Center
- Cancer Treatment Centers of America
- University of Pennsylvania Hospital
- Eastern Regional Medical Center
- Virginia Cancer Specialists
- University of Wisconsin-Madison Hospital and Health Clinic
- NSW Health - Sydney Local Health District
- Royal North Shore Hospital
- Queensland Health - Metro North Hospital and Health Service
- Linear Clinical Research
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
- AP-HM
- Universitätsklinikum Würzburg A. ö. R.
- Universitätsklinikum Köln
- Charité Campus Virchow-Klinikum
- Shaare Zedek Medical Center
- Soroka Medical Center - Pediatric Outpatient Clinic
- Istituto Nazionale dei Tumori
- Azienda Ospedaliero Universitaria Pisana
- ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
- National Cancer Center Hospital East
- Hokkaido University Hospital
- Kanazawa University Hospital
- National Cancer Center Hospital
- Tottori University Hospital
- Osaka City General Hospital
- University of Auckland
- Centrum Onkologii Instytut im Marii Curie w Warszawie
- National Cancer Centre Singapore
- Hospital Universitari Vall d'Hebron
- Hospital Madrid Norte Sanchinarro
- Kantonsspital Luzern
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03906331
First Posted
April 4, 2019
Last Updated
September 29, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03906331
Brief Title
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
2. Study Status
Record Verification Date
September 15, 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Selpercatinib
Other Intervention Name(s)
LOXO-292, LY3527723
Intervention Description
Open-label expanded access
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Treatment Centers of America
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
623-207-3000
First Name & Middle Initial & Last Name & Degree
Ashish Sangal
Facility Name
Mayo Clinic of Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
480-301-8000
First Name & Middle Initial & Last Name & Degree
Nina Karlin
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-0269
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
626-256-4673
First Name & Middle Initial & Last Name & Degree
Erminia Massarelli
Facility Name
Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
714-456-8000
First Name & Middle Initial & Last Name & Degree
Viola Zhu
Facility Name
University of California - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
858-534-2230
First Name & Middle Initial & Last Name & Degree
Lyudmila Bazhenova
Facility Name
Univ of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
415-353-7552
First Name & Middle Initial & Last Name & Degree
Alain Algazi
Facility Name
Memorial Cancer Institute
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
305-243-1000
First Name & Middle Initial & Last Name & Degree
Luis Raez
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
904-953-2000
First Name & Middle Initial & Last Name & Degree
Victor Bernet
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
407-303-0409
First Name & Middle Initial & Last Name & Degree
Mark Socinski
Facility Name
Tallahassee Memorial Cancer Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
850-431-5360
First Name & Middle Initial & Last Name & Degree
Karen B. Russell
Facility Name
University Cancer and Blood Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
706-353-2990
First Name & Middle Initial & Last Name & Degree
Petros Nikolinakos
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329-5102
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
404-727-6123
First Name & Middle Initial & Last Name & Degree
Taofeek Owonikoko
Facility Name
University of Chicago Medicine-Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
630-862-5757
First Name & Middle Initial & Last Name & Degree
Christine Bestvina
Facility Name
Cancer Treatment Centers of America
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
847-872-6324
First Name & Middle Initial & Last Name & Degree
Eugene Ahn
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
617-632-5869
First Name & Middle Initial & Last Name & Degree
Geoffrey Oxnard
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
734-647-8902
First Name & Middle Initial & Last Name & Degree
Francis Worden
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
616-954-5554
First Name & Middle Initial & Last Name & Degree
Nehal Lakhani
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
5072844080
First Name & Middle Initial & Last Name & Degree
John Columbus Morris
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
646-888-4206
First Name & Middle Initial & Last Name & Degree
Alexander Drilon
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
216-444-1128
First Name & Middle Initial & Last Name & Degree
Nathan Pennell
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
614-293-3873
First Name & Middle Initial & Last Name & Degree
Manisha Shah
Facility Name
Cancer Treatment Centers of America
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
918-286-5689
First Name & Middle Initial & Last Name & Degree
Issam Alawin
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
215-898-8796
First Name & Middle Initial & Last Name & Degree
Marcia Brose
Facility Name
Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
215-537-4555
First Name & Middle Initial & Last Name & Degree
Arturo Loaiza-Bonilla
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
703-280-5390
First Name & Middle Initial & Last Name & Degree
Alexander Spira
Facility Name
University of Wisconsin-Madison Hospital and Health Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-4108
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Burkard
Facility Name
NSW Health - Sydney Local Health District
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Available
Facility Contact:
Phone
610295156111
First Name & Middle Initial & Last Name & Degree
Michael Joseph Boyer
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bruce robinson
Facility Name
Queensland Health - Metro North Hospital and Health Service
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Available
Facility Contact:
Phone
0731394000
First Name & Middle Initial & Last Name & Degree
Brett Hughes
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Available
Facility Contact:
Phone
611300546327
First Name & Middle Initial & Last Name & Degree
samantha bowyer
Facility Name
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Individual Site Status
Available
Facility Contact:
Phone
33556333244
First Name & Middle Initial & Last Name & Degree
Antoine Italiano
Facility Name
AP-HM
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Available
Facility Contact:
Phone
33 0491385416
First Name & Middle Initial & Last Name & Degree
Pascale Tomasini
Facility Name
Universitätsklinikum Würzburg A. ö. R.
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Available
Facility Contact:
Phone
49 931201 39939
First Name & Middle Initial & Last Name & Degree
Matthias Kroiss
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Available
Facility Contact:
Phone
492214783993
First Name & Middle Initial & Last Name & Degree
Jürgen Wolf
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Available
Facility Contact:
Phone
493045050
First Name & Middle Initial & Last Name & Degree
Damian Tobias Rieke
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nir Peled
Facility Name
Soroka Medical Center - Pediatric Outpatient Clinic
City
Beer-Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Dudnik
Facility Name
Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardie
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo De Braud
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Available
Facility Contact:
Phone
390502212111
First Name & Middle Initial & Last Name & Degree
Rossella Elisei
Facility Name
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Available
Facility Contact:
Phone
390264442464
First Name & Middle Initial & Last Name & Degree
Salvatore Siena
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Available
Facility Contact:
Phone
81471331111
First Name & Middle Initial & Last Name & Degree
Koichi Goto
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Sakakibara
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Available
Facility Contact:
Phone
81762652000
First Name & Middle Initial & Last Name & Degree
Shinji Takeuchi
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Available
Facility Contact:
Phone
81335422511
First Name & Middle Initial & Last Name & Degree
YUICHIRO OHE
Facility Name
Tottori University Hospital
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Individual Site Status
Available
Facility Contact:
Phone
81859331111
First Name & Middle Initial & Last Name & Degree
Tomohiro Sakamoto
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Available
Facility Contact:
Phone
81669291221
First Name & Middle Initial & Last Name & Degree
Haruko Daga
Facility Name
University of Auckland
City
Auckland
ZIP/Postal Code
91346
Country
New Zealand
Individual Site Status
Available
Facility Contact:
Phone
6493737999
First Name & Middle Initial & Last Name & Degree
Mark McKeage
Facility Name
Centrum Onkologii Instytut im Marii Curie w Warszawie
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Individual Site Status
Available
Facility Contact:
Phone
0048225463380
First Name & Middle Initial & Last Name & Degree
Iwona Lugowska
Facility Name
National Cancer Centre Singapore
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Available
Facility Contact:
Phone
654368000
First Name & Middle Initial & Last Name & Degree
Shao Weng Daniel Tan
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Available
Facility Contact:
Phone
934893000
First Name & Middle Initial & Last Name & Degree
Elena Garralda Cabanas
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Available
Facility Contact:
Phone
034 91 756 7825
First Name & Middle Initial & Last Name & Degree
Maria Jose Miguel Luken
Facility Name
Kantonsspital Luzern
City
Luzern 16
State/Province
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Available
Facility Contact:
Phone
412051111
First Name & Middle Initial & Last Name & Degree
Oliver Gautschi
12. IPD Sharing Statement
Learn more about this trial
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
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