Trial · NCT02808650

Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

NCT02808650, Phase 1, Completed, Children's Oncology Group; results first posted 2023-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors. Trials, record NCT02808650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02808650

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
NCT number: NCT02808650
Status: Completed
Phases: Phase 1
Enrollment: 30 participants, actual
Lead sponsor: Children's Oncology Group
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: Laboratory Biomarker Analysis, Pharmacokinetic (PK) study, Prexasertib
First posted: 2016-06-22
Last updated: 2023-12-20
Results first posted: 2023-12-20

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) of Prexasertib	Up to 28 days	Maximum tolerated dose or recommended phase 2 dose of prexasertib assessed by national Cancer Institute (NCI) CTCAE version 4.0 defined as the maximum dose at which fewer that one-third of patients experience a dose limiting toxicity in cycle 1
Primary	Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Up to 28 days	Number of patients with DLT to Prexasertib by dose level and study part.
Primary	Area Under the Concentration Time Curve for Prexasertib	Up to 8 hours	Median (min, max) area under the concentration by time curve for prexasertib assessed at 1, 1.5, 2, 4, and 8 hours on day 1 post infusion by dose level and study part
Secondary	Antitumor Activity of Prexasertib	Up to 2 years	Number of response evaluable patients with response (CR/PR) using the RECIST guideline version 1.1 including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in the sum of the diameters of target lesions by dose level and study part
Secondary	CHK1/2 Expression Status	Up to 2 years	Number of patients with CHK1/2 expression by percent of tumor cells with CHK1/2 expression defined by quartiles.
Secondary	TP53 Deletion and/or Mutation in Tumor Tissue as a Potential Biomarker of Chk1 Inhibition	Up to 2 years	Number of patients with TP53 deletion and/or mutation of Trp53 by percent of tumor cells with TP53 deletion and/or mutation of Trp53 defined by quartiles.
Secondary	Autophosphorylation of CHK1 and H2AX	Up to 2 years	Median (min, max) autophosphorylation of CHK1 and H2AX in peripheral blood mononuclear cells by dose level and study part.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) of Prexasertib	Up to 28 days		mg/m^2	NUMBER
PRIMARY	Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Up to 28 days	All Toxicity evaluable patients	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Area Under the Concentration Time Curve for Prexasertib	Up to 8 hours		hr*ng/mL	MEDIAN
SECONDARY	Antitumor Activity of Prexasertib	Up to 2 years	Eligible Patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	CHK1/2 Expression Status	Up to 2 years	All eligible patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	TP53 Deletion and/or Mutation in Tumor Tissue as a Potential Biomarker of Chk1 Inhibition	Up to 2 years	Response evaluable Patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Autophosphorylation of CHK1 and H2AX	Up to 2 years	Testing failed. Data not available to be reported for outcome measure.

Source ClinicalTrials.gov

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose (MTD) of Prexasertib	Treatment (Prexasertib)	150		mg/m^2
Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Part A Dose Level 1: 80 mg/m^2	0		Participants
Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Part A Dose Level 2: 100 mg/m^2	0		Participants
Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Part A Dose Level 3: 125 mg/m^2	0		Participants
Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Part A Dose Level 4: 150 mg/m^2	0		Participants
Number of Patients With Dose Limiting Toxicity (DLT) to Prexasertib	Part PK Dose Level 4: 150 mg/m^2	0		Participants
Area Under the Concentration Time Curve for Prexasertib	Part A Dose Level 1: 80 mg/m^2	1718.7	Full Range 1215.2 to 2168.6	hr*ng/mL
Area Under the Concentration Time Curve for Prexasertib	Part A Dose Level 2: 100 mg/m^2	2285.5	Full Range 1658.4 to 3529.0	hr*ng/mL
Area Under the Concentration Time Curve for Prexasertib	Part A Dose Level 3: 125 mg/m^2	2534.4	Full Range 2080.0 to 3535.6	hr*ng/mL
Area Under the Concentration Time Curve for Prexasertib	Part A Dose Level 4: 150 mg/m^2	4206.6	Full Range 2164.9 to 5357.9	hr*ng/mL

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Part A Dose Level 1: 80 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 2: 100 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 3: 125 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 4: 150 mg/m^2	6
Overall Study	STARTED	Part PK Dose Level 4: 150 mg/m^2	6
Overall Study	COMPLETED	Part A Dose Level 1: 80 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 2: 100 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 3: 125 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 4: 150 mg/m^2	0
Overall Study	COMPLETED	Part PK Dose Level 4: 150 mg/m^2	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events1,285

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 1: 80 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 2: 100 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 3: 125 mg/m^2	1	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 4: 150 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part PK Dose Level 4: 150 mg/m^2	1	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 1: 80 mg/m^2	1	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 2: 100 mg/m^2	0	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 3: 125 mg/m^2	0	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 4: 150 mg/m^2	1	6
other	Abdominal pain	Gastrointestinal disorders	Part PK Dose Level 4: 150 mg/m^2	1	6

1 to 10 of 1,285Source ClinicalTrials.gov

See all 1,285 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part A Dose Level 1: 80 mg/m^2	1	6
Total, all-cause mortality	Part A Dose Level 2: 100 mg/m^2	1	6
Total, all-cause mortality	Part A Dose Level 3: 125 mg/m^2	0	6
Total, all-cause mortality	Part A Dose Level 4: 150 mg/m^2	0	6
Total, all-cause mortality	Part PK Dose Level 4: 150 mg/m^2	1	6
Total, other adverse events	Part A Dose Level 1: 80 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 2: 100 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 3: 125 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 4: 150 mg/m^2	6	6
Total, other adverse events	Part PK Dose Level 4: 150 mg/m^2	6	6

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33881209	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1CA097452	Pediatric Phase 1/Pilot Consortium	WEIGEL, BRENDA J.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2009 to 2018

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02808650

GET https://conductscience.org/api/trials/v1/NCT02808650/results?page=2

API reference For AI assistants