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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03906331




Registration number
NCT03906331
Ethics application status
Date submitted
4/04/2019
Date registered
8/04/2019
Date last updated
2/10/2023

Titles & IDs
Public title
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Scientific title
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Secondary ID [1] 0 0
Selpercatinib EAP
Secondary ID [2] 0 0
17494
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Medullary Thyroid Cancer 0 0
Colon Cancer 0 0
Breast Cancer 0 0
Pancreatic Cancer 0 0
Papillary Thyroid Cancer 0 0
Other Solid Tumors With Evidence of Activating RET Alteration 0 0
Condition category
Condition code
Cancer 0 0 0 0
Thyroid
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Selpercatinib

Treatment: Drugs: Selpercatinib
Open-label expanded access
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
NSW Health - Sydney Local Health District - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Queensland Health - Metro North Hospital and Health Service - Chermside
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
France
State/province [15] 0 0
Aquitaine
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
Germany
State/province [17] 0 0
Bayern
Country [18] 0 0
Germany
State/province [18] 0 0
Nordrhein-Westfalen
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Israel
State/province [20] 0 0
Yerushalayim
Country [21] 0 0
Israel
State/province [21] 0 0
Beer-Sheva
Country [22] 0 0
Italy
State/province [22] 0 0
Lombardie
Country [23] 0 0
Italy
State/province [23] 0 0
PI
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Japan
State/province [25] 0 0
Chiba
Country [26] 0 0
Japan
State/province [26] 0 0
Hokkaido
Country [27] 0 0
Japan
State/province [27] 0 0
Ishikawa
Country [28] 0 0
Japan
State/province [28] 0 0
Tokyo
Country [29] 0 0
Japan
State/province [29] 0 0
Tottori
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
New Zealand
State/province [31] 0 0
Auckland
Country [32] 0 0
Poland
State/province [32] 0 0
Warszawa
Country [33] 0 0
Singapore
State/province [33] 0 0
Central Singapore
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona [Barcelona]
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Switzerland
State/province [36] 0 0
Luzern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Loxo Oncology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03906331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03906331