Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-29 @ 10:55 AM
Study NCT ID:
NCT02808650
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: