Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT03906331
Collaborator
Eli Lilly and Company (Industry)
68
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
N/A for expanded access
Study Design
Study Type:
Expanded Access
Official Title:
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Treatment Centers of America | Goodyear | Arizona | United States | 85338 |
| 2 | Mayo Clinic of Scottsdale | Scottsdale | Arizona | United States | 85259 |
| 3 | City of Hope National Medical Center | Duarte | California | United States | 91010-0269 |
| 4 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 5 | Kaiser Permanente | Oakland | California | United States | 94612 |
| 6 | Irvine Medical Center | Orange | California | United States | 92868 |
| 7 | Kaiser Permanente Medical Center | Sacramento | California | United States | 95814 |
| 8 | University of California - San Diego | San Diego | California | United States | 92103 |
| 9 | Kaiser Permanente Medical Center | San Francisco | California | United States | 94115 |
| 10 | Univ of California San Francisco | San Francisco | California | United States | 94115 |
| 11 | Kaiser Permanente | Santa Clara | California | United States | 95051 |
| 12 | Kaiser Permanente Medical Center | Vallejo | California | United States | 94589 |
| 13 | Memorial Cancer Institute | Hollywood | Florida | United States | 33021 |
| 14 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224 |
| 15 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 16 | Tallahassee Memorial Cancer Center | Tallahassee | Florida | United States | 32308 |
| 17 | University Cancer and Blood Center | Athens | Georgia | United States | 30607 |
| 18 | Emory University | Atlanta | Georgia | United States | 30329-5102 |
| 19 | University of Chicago Medicine-Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 20 | Cancer Treatment Centers of America | Zion | Illinois | United States | 60099 |
| 21 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 22 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 23 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 24 | START Midwest | Grand Rapids | Michigan | United States | 49546 |
| 25 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 26 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 27 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 28 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 29 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 30 | Cancer Treatment Centers of America | Tulsa | Oklahoma | United States | 74133 |
| 31 | University of Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19104 |
| 32 | Eastern Regional Medical Center | Philadelphia | Pennsylvania | United States | 19124 |
| 33 | Oncology Consultants | Houston | Texas | United States | 77030 |
| 34 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 35 | Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
| 36 | University of Wisconsin-Madison Hospital and Health Clinic | Madison | Wisconsin | United States | 53792-4108 |
| 37 | NSW Health - Sydney Local Health District | Camperdown | New South Wales | Australia | 2050 |
| 38 | Royal North Shore Hospital | St. Leonards | New South Wales | Australia | 2065 |
| 39 | Queensland Health - Metro North Hospital and Health Service | Chermside | Queensland | Australia | 4032 |
| 40 | Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia | 3000 |
| 41 | Linear Clinical Research | Nedlands | Western Australia | Australia | 6009 |
| 42 | Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | Aquitaine | France | 33076 |
| 43 | Centre Leon Berard | Lyon Cedex 08 | France | 69373 | |
| 44 | AP-HM | Marseille | France | 13005 | |
| 45 | Gustave Roussy | Villejuif Cedex | France | 94805 | |
| 46 | Universitätsklinikum Würzburg A. ö. R. | Würzburg | Bayern | Germany | 97080 |
| 47 | Universitätsklinikum Köln | Köln | Nordrhein-Westfalen | Germany | 50937 |
| 48 | Charité Campus Virchow-Klinikum | Berlin | Germany | 13353 | |
| 49 | Prince of Wales Hospital | Hong Kong | Shatin, New Territories | Hong Kong | |
| 50 | Sheba Medical Center | Ramat Gan | HaMerkaz | Israel | 5262100 |
| 51 | Shaare Zedek Medical Center | Jerusalem | Yerushalayim | Israel | 9103102 |
| 52 | Soroka Medical Center - Pediatric Outpatient Clinic | Beer-Sheva | Israel | 8410101 | |
| 53 | Istituto Nazionale dei Tumori | Milano | Lombardie | Italy | 20133 |
| 54 | Azienda Ospedaliero Universitaria Pisana | Pisa | PI | Italy | 56124 |
| 55 | ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C | Milano | Italy | 20162 | |
| 56 | National Cancer Center Hospital East | Kashiwa | Chiba | Japan | 277-8577 |
| 57 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
| 58 | Kanazawa University Hospital | Kanazawa | Ishikawa | Japan | 920-8641 |
| 59 | National Cancer Center Hospital | Chuo-ku | Tokyo | Japan | 104-0045 |
| 60 | Tottori University Hospital | Yonago | Tottori | Japan | 683-8504 |
| 61 | Osaka City General Hospital | Osaka | Japan | 534-0021 | |
| 62 | University of Auckland | Auckland | New Zealand | 91346 | |
| 63 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
| 64 | Centrum Onkologii Instytut im Marii Curie w Warszawie | Warszawa | Poland | 02-034 | |
| 65 | National Cancer Centre Singapore | Singapore | Central Singapore | Singapore | 169610 |
| 66 | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | Spain | 8035 |
| 67 | Hospital Madrid Norte Sanchinarro | Madrid | Spain | 28050 | |
| 68 | Kantonsspital Luzern | Luzern 16 | Luzern | Switzerland | 6000 |
Sponsors and Collaborators
- Loxo Oncology, Inc.
- Eli Lilly and Company
Investigators
- Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Loxo Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT03906331
Other Study ID Numbers:
- 17494
- Selpercatinib EAP
- J2G-OX-Y001
First Posted:
Apr 8, 2019
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 15, 2022