Breast Cancer Clinical Trial

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

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.

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Full 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.

View Eligibility Criteria

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])

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT03899792

Recruitment Status:

Recruiting

Sponsor:

Loxo Oncology, Inc.

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There are 27 Locations for this study

See Locations Near You

Childrens Hospital of Los Angeles
Los Angeles California, 90027, United States More Info
Contact
323-669-2101
Leo Mascarenhas
Principal Investigator
Lucile Packard Children's Hospital
Palo Alto California, 94304, United States More Info
Contact
650-723-5535
Sheri L Spunt
Principal Investigator
The Children's Hospital for Cancer and Blood Disorders
Aurora Colorado, 80045, United States More Info
Contact
720-777-6458
Margaret Macy
Principal Investigator
Nemours Children's Health
Orlando Florida, 32827, United States More Info
Ramamoorthy Nagasubramanian
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Contact
617-632-5869
Steven G DuBois
Principal Investigator
University of Minnesota Hospital
Minneapolis Minnesota, 55454, United States More Info
Contact
612-273-9820
Emily Greengard
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Contact
212-639-6729
Julia L Glade Bender
Principal Investigator
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States More Info
Contact
513-636-7329
Brian Turpin
Principal Investigator
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States More Info
Contact
267-426-9338
Frank M Balis
Principal Investigator
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States More Info
Contact
901-595-2813
Alberto Pappo
Principal Investigator
University of Texas Southwestern Medical Center at Dallas
Dallas Texas, 75390, United States More Info
Contact
214-456-6363
Tanya Watt
Principal Investigator
Texas Childrens Hospital
Houston Texas, 77025, United States More Info
Contact
713-770-3453
Stephanie Fetzko
Principal Investigator
Seattle Children's Hospital Research Foundation
Seattle Washington, 98105, United States More Info
Contact
206-987-2114
Douglas Hawkins
Principal Investigator
The Children's Hospital at Westmead
Sydney New South Wales, 2031, Australia More Info
Contact
61293821730
David Ziegler
Principal Investigator
Royal Children's Hospital
Parkville Victoria, 3052, Australia More Info
Martin Campbell
Principal Investigator
The Hospital for Sick Children
Toronto Ontario, M5G 1, Canada More Info
Contact
416.813.7654
Daniel Alexander Morgenstern
Principal Investigator
Rigshospitalet
Copenhagen , 2200, Denmark More Info
Contact
4535453545
Karstend Nysom
Principal Investigator
Gustave Roussy
Villejuif Cedex , 94805, France More Info
Birgit Geoerger
Principal Investigator
Universitätsklinikum Heidelberg
Heidelberg Baden-Württemberg, 69120, Germany More Info
Cornelis Van Tilburg
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan Lombardia, 20133, Italy More Info
Contact
+390223902588
Michela Casanova
Principal Investigator
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan More Info
Contact
81 117161161
Atushi Manabe Manabe
Principal Investigator
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan More Info
Contact
81335422511
Ayumu Arakawa
Principal Investigator
Hiroshima University Hospital
Hiroshima , 734-8, Japan More Info
Contact
81822575555
Shuhei Karakawa
Principal Investigator
Kyoto University Hospital
Kyoto , 606-8, Japan More Info
Contact
81757513111
Katsutsugu Umeda
Principal Investigator
Seoul National University Hospital
Seoul Korea, 03080, Korea, Republic of More Info
HyoungJin Kang
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [Barcelona], 8035, Spain More Info
Contact
934893000
Raquel Hladun
Principal Investigator
University College Hospital - London
London Greater London, NW1 2, United Kingdom More Info
Sara Stoneham
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT03899792

Recruitment Status:

Recruiting

Sponsor:


Loxo Oncology, Inc.

How clear is this clinincal trial information?

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