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

  • STATUS
    Recruiting
  • End date
    Mar 26, 2024
  • participants needed
    100
  • sponsor
    Loxo Oncology, Inc.
Updated on 24 November 2021
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 Connective and Soft Tissue Neoplasm, Sarcoma, All Solid Tumors, Solid Tumors, Papillary Thyroid Cancer, Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Papillary Thyroid Carcinoma, Thyroid Papillary Carcinoma, Sarcoma (Pediatric), Infantile Fibrosarcoma, Soft Tissue Sarcoma, Infantile Myofibromatosis, sarcomas, soft tissue sarcomas, pact
Treatment LOXO-292
Clinical Study IdentifierNCT03899792
SponsorLoxo Oncology, Inc.
Last Modified on24 November 2021

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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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