NCT02808650

Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

A Phase 1 Study of LY2606368 (Prexasertib Mesylate Monohydrate) a CHK1/2 Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 12 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of prexasertib in treating pediatric patients with solid tumors that have come back after a period of time during which the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1 inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of prexasertib (LY2606368) administered as an intravenous (IV) infusion over 60 minutes, every 14 days of a 28-day cycle to children with recurrent or refractory solid tumors. II. To define and describe the toxicities of LY2606368 administered on this schedule. III. To characterize the pharmacokinetics of LY2606368 in children with recurrent or refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of LY2606368 within the confines of a phase 1 study. II. To examine checkpoint kinase (CHK)1/2 expression status in archival tumor tissue from solid tumor pediatric patients using immunohistochemistry. III. To evaluate tumor tissue for deletion and/or mutation of tumor protein 53 (TP53) as a potential biomarker of Chk1 inhibition. IV. To evaluate autophosphorylation of Chk1 and H2A histone family, member x (H2AX) in peripheral blood mononuclear cells as a potential pharmacodynamic marker of LY2606368 activity. OUTLINE: This is a dose-escalation study. Patients receive prexasertib IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Conditions

• Childhood Solid Neoplasm
• Recurrent Malignant Solid Neoplasm
• Recurrent Primary Central Nervous System Neoplasm
• Refractory Malignant Solid Neoplasm
• Refractory Primary Central Nervous System Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacokinetic (PK) study	Correlative studies
DRUG	Prexasertib	Given IV

Timeline

• Start date: 2017-02-27
• Primary completion: 2019-12-31
• Completion: 2021-03-31
• First posted: 2016-06-22
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study