Trial Title:
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
NCT ID:
NCT03899792
Condition:
Medullary Thyroid Cancer
Infantile Myofibromatosis
Infantile Fibrosarcoma
Papillary Thyroid Cancer
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Thyroid Neoplasms
Thyroid Cancer, Papillary
Fibrosarcoma
Myofibromatosis
Thyroid Diseases
Conditions: Keywords:
Loxo
LOXO-292
KIF5B-RET
M918T
CCDC6-RET
RET-PTC1
NCOA4-RET
RET-PTC
RET-PTC3
RET-PTC4
PRKAR1A-RET
RET-PTC2
GOLGA5-RET
RET-PTC5
ERC1-RET
KTN1-RET
RET-PTC8
HOOK3-RET
PCM1-RET
TRIM24-RET
RET-PTC6
TRIM27-RET
TRIM33-RET
RET-PTC7
AKAP13-RET
FKBP15-RET
SPECC1L-RET
TBL1XR1-RET
BCR-RET
FGRF1OP-RET
RFG8-RET
RET-PTC9
ACBD5-RET
MYH13-RET
CUX1-RET
KIAA1468-RET
FRMD4A-RET
SQSTM1-RET
AFAP1L2-RET
PPFIBP2-RET
EML4-RET
PARD3-RET
G533C
C609F
C609G
C609R
C609S
C609Y
C611F
C611G
C611S
C611Y
C611W
C618F
C618R
C618S
C620F
C620R
C620S
C630R
C630Y
D631Y
C634F
C634G
C634R
C634S
C634W
C634Y
K666E
E768D
L790F
V804L
V804M
A883F
S891A
R912P
CLIP1-RET
Y806C
RET fusion
RET alteration
RET mutation
RET rearrangement
RET translocation
Neoplasms by Site
Neoplasms
Non-Small Cell Lung Cancer
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Respiratory Tract Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Medullary Thyroid Cancer
Papillary Thyroid Cancer
Thyroid Diseases
Thyroid Neoplasms
Cancer of the Thyroid
Cancer of Thyroid
Neoplasms, Thyroid
Thyroid Adenoma
Thyroid Cancer
Thyroid Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Thoracic Neoplasms
CNS tumor
Primary CNS tumor
Colonic Neoplasms
Cancer of Colon
Cancer of the Colon
Colon Cancer
Colon Neoplasms
Colonic Cancer
Neoplasms, Colonic
Malignant tumor of Breast
Mammary Cancer
Mammary Carcinoma, Human
Mammary Neoplasm, Human
Neoplasms, Breast
Tumors, Breast
Human Mammary Carcinoma
Malignant Neoplasm of Breast
Breast Carcinoma
Breast Tumors
Cancer of the Breast
Breast Neoplasms
Breast Cancer
RET Inhibitor
MTC
NSCLC
Soft tissue sarcoma
Infantile Myofibromatosis
Infantile Fibrosarcoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LOXO-292
Description:
Oral LOXO-292
Arm group label:
LOXO-292
Other name:
Selpercatinib
Other name:
LY3527723
Summary:
This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric
participants with an activating rearranged during transfection (RET) alteration and an
advanced solid or primary CNS tumor.
Detailed description:
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In
phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The
starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160
milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or
recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of
four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype.
Cycle length will be 28 days.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Advanced or metastatic solid or primary CNS tumor which has failed standard of care
therapies
- Evidence of an activating RET gene alteration in the tumor and/or blood
- Measurable or non-measurable disease
- Karnofsky (participants 16 years and older) or Lansky (participants younger than 16)
performance score of at least 50
- Participant with primary CNS tumors or cerebral metastases must be neurologically
stable for 7 days prior and must not have required increasing doses of steroids
within the last 7 days
- Adequate hematologic, hepatic and renal function.
- Ability to receive study drug therapy orally or via gastric access
- Willingness of men and women of reproductive potential to observe conventional and
effective birth control
Exclusion Criteria:
- Major surgery within two weeks prior to planned start of LOXO-292
- Clinically significant, uncontrolled cardiac, cardiovascular disease or history of
myocardial infarction within 6 months prior to planned start of LOXO-292
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
- Clinically significant active malabsorption syndrome
- Pregnancy or lactation
- Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant
required a modification to current thyroid medication in the 7 days before start of
LOXO-292)
- Uncontrolled symptomatic hypercalcemia or hypocalcemia
- Known hypersensitivity to any of the components of the investigational agent,
LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292
suspension
- Prior treatment with a selective RET inhibitor(s) (including investigational
selective RET inhibitor[s])
Gender:
All
Minimum age:
6 Months
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Childrens Hospital of Los Angeles
Address:
City:
Los Angeles
Zip:
90027
Country:
United States
Status:
Recruiting
Contact:
Phone:
323-669-2101
Investigator:
Last name:
Leo Mascarenhas
Email:
Principal Investigator
Facility:
Name:
The Children's Hospital for Cancer and Blood Disorders
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
720-777-6458
Investigator:
Last name:
Margaret Macy
Email:
Principal Investigator
Facility:
Name:
Nemours Children's Health
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
+91 407567 4000
Investigator:
Last name:
Ramamoorthy Nagasubramanian
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
617-632-5869
Investigator:
Last name:
Steven DuBois
Email:
Principal Investigator
Facility:
Name:
University Of Minnesota Hospital
Address:
City:
Minneapolis
Zip:
55454
Country:
United States
Status:
Recruiting
Contact:
Phone:
612-273-9820
Investigator:
Last name:
Emily Greengard
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
212-639-6729
Investigator:
Last name:
Julia Glade Bender
Email:
Principal Investigator
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229-3039
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
513-636-7329
Investigator:
Last name:
Brian Turpin
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Phone:
267-426-9338
Investigator:
Last name:
Frank Balis
Email:
Principal Investigator
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Phone:
901-595-2813
Investigator:
Last name:
Alberto Pappo
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern Medical Center at Dallas
Address:
City:
Dallas
Zip:
75390-9063
Country:
United States
Status:
Recruiting
Contact:
Phone:
214-456-6363
Investigator:
Last name:
Tanya Watt
Email:
Principal Investigator
Facility:
Name:
Texas Childrens Hospital
Address:
City:
Houston
Zip:
77025
Country:
United States
Status:
Recruiting
Contact:
Phone:
713-770-3453
Investigator:
Last name:
Stephanie Fetzko
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital Research Foundation
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Phone:
206-987-2114
Investigator:
Last name:
Douglas Hawkins
Email:
Principal Investigator
Facility:
Name:
The Children's Hospital at Westmead
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61293821730
Investigator:
Last name:
David Ziegler
Email:
Principal Investigator
Facility:
Name:
Royal Children's Hospital
Address:
City:
Parkville
Zip:
3052
Country:
Australia
Status:
Recruiting
Contact:
Phone:
+ 61 3 93459180
Investigator:
Last name:
Martin Campbell
Email:
Principal Investigator
Facility:
Name:
The Hospital for Sick Children
Address:
City:
Toronto
Zip:
M5G 1X8
Country:
Canada
Status:
Recruiting
Contact:
Phone:
416.813.7654
Investigator:
Last name:
Daniel Alexander Morgenstern
Email:
Principal Investigator
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2200
Country:
Denmark
Status:
Recruiting
Contact:
Phone:
4535453545
Investigator:
Last name:
Karstend Nysom
Email:
Principal Investigator
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Phone:
+33 1.42.11.46.61
Investigator:
Last name:
Charlotte Rigaud
Email:
Principal Investigator
Facility:
Name:
Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Phone:
+49 6221 56-36926
Investigator:
Last name:
Cornelis Van Tilburg
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Phone:
+390223902588
Investigator:
Last name:
Michela Casanova
Email:
Principal Investigator
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81 117161161
Investigator:
Last name:
Atushi Manabe
Email:
Principal Investigator
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81335422511
Investigator:
Last name:
Ayumu Arakawa
Email:
Principal Investigator
Facility:
Name:
Hiroshima University Hospital
Address:
City:
Hiroshima
Zip:
734-8551
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81822575555
Investigator:
Last name:
Shuhei Karakawa
Email:
Principal Investigator
Facility:
Name:
Kyoto University Hospital
Address:
City:
Kyoto
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Contact:
Phone:
81757513111
Investigator:
Last name:
Katsutsugu Umeda
Email:
Principal Investigator
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Phone:
82-2-2072-3304
Investigator:
Last name:
HyoungJin Kang
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Contact:
Phone:
934893000
Investigator:
Last name:
Raquel Hladun
Email:
Principal Investigator
Facility:
Name:
University College Hospital - London
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Sara Stoneham
Email:
Principal Investigator
Start date:
June 13, 2019
Completion date:
May 31, 2029
Lead sponsor:
Agency:
Loxo Oncology, Inc.
Agency class:
Industry
Collaborator:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT03899792
