ADVL1515: Prexasertib for Children with Recurrent or Refractory Solid Tumors

A Phase I Study of LY2606368 (prexasertib mesylate monohydrate), A CHK1/2 Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors


Solid Tumor

Phase I/II

Diseases Treated:

Solid Tumor, CNS Tumor

Eligibility Overview:

  • 12 months to 21 years old
  • Diagnosis of recurrent or refractory solid tumor, including CNS tumor
  1. Brief Summary

    This Phase I study will examine the safety and pharmacokinetics of prexasertib, also known as LY2606368, in children and young adults with refractory or recurrent solid tumors, including CNS tumors. Prexasertib is a novel, second generation selective, dual inhibitor of CHK1/2. In vitro studies focused in cell lines derived from human pediatric tumors (ALL, Ewing’s sarcoma, medulloblastoma, neuroblastoma, osteosarcoma, retinoblastoma and rhabdomyosarcoma) indicate that prexasertib is a potent inhibitor of cell proliferation. The antitumor activity of prexasertib has also been evaluated in 14 pediatric tumor xenograft models. There have been no pediatric studies of prexasertib.

    Primary Objectives

    • To estimate the maximum tolerated dose (MTD) and/or recommended Phase II dose of prexasertib administered as an intravenous infusion over 60 minutes, every 14 days of a 28-day cycle to children with recurrent or refractory solid tumors
    • To definite and describe the toxicities of prexasertib administered on this schedule
    • To characterize the pharmacokinetics of prexasertib in children with recurrent or refractory cancer

    Eligibility Criteria

    Inclusion criteria include:

    • 12 months to 21 years old
    • Diagnosis of recurrent or refractory solid tumor, including CNS tumor 
    • Recovered from acute toxic effects of prior anti-cancer therapy and meets minimum duration from prior anti-cancer directed therapy prior to enrollment
    • No prior exposure to prexasertib 
    • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life

    Exclusion Criteria include:

    • Pregnancy or breastfeeding
    • Currently receiving another investigational drug
    • Currently receiving other anti-cancer agents
    • History of allergy to compounds of similar chemical or biologic composition to prexasertib or its formulation

    Study Sites

    St. Jude Children's Research Hospital
    Memphis, Tennessee

    Collaborating sites in the U.S.

  2. About this study

    This clinical trial is a research study of an experimental drug for cancer. The drug is called prexasertib, also known as LY2606368. It is considered experimental because it has not been proven to work in children and young adults with solid tumors that have come back (recurrent) or are hard to treat (refractory). Prexasertib seems to work against cancer in laboratory studies. It has been used in adults, but it has not been approved for use in children. This study will test prexasertib in children and young adults with hard-to-treat solid tumors.

    Purpose of this clinical trial

    The main purpose of this study is to find the highest dose of prexasertib that may be given safely without causing severe side effects. Researchers also want to learn more about how the body handles the drug. Finally, they want to see how well prexasertib treats recurrent and refractory solid tumors in children and young adults.

    Eligibility overview

    • 12 months to 21 years old
    • Diagnosis of recurrent or refractory solid tumor, including CNS tumor
  3. ADVL1515 Quick VIew
    Sponsors Children's Oncology Group identifier NCT02808650
    Trial Start Date February 2017
    Estimated Enrollment 65
    Study Type Interventional
    Study Phase Phase I
    Conditions Solid tumors
    Ages 12 months to 21 years old
    Principal investigator Wayne Furman, MD (St. Jude)
    Study Sites St. Jude Children's Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss ADVL1515 St. Jude Physician/Patient Referral Office

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.