A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors (LIBRETTO-121)

STATUS

Recruiting
End date

Mar 26, 2024
participants needed

100
sponsor

Loxo Oncology, Inc.

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Updated on 20 October 2022

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renal function

measurable disease

kidney function tests

metastasis

RET

cns tumor

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.

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.

Details

Condition	Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma
Treatment	LOXO-292
Clinical Study Identifier	NCT03899792
Sponsor	Loxo Oncology, Inc.
Last Modified on	20 October 2022

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Eligibility		Yes	No	Not Sure
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])

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A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors (LIBRETTO-121)