Trial · NCT03323034

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma

NCT03323034, Phase 1, Completed, Children's Oncology Group; results first posted 2022-09-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma. Trials, record NCT03323034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03323034

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Trial

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

Title: Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma
NCT number: NCT03323034
Status: Completed
Phases: Phase 1
Enrollment: 30 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Primary Central Nervous System Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Primary Central Nervous System Neoplasm
Interventions: Irinotecan, Pevonedistat, Temozolomide
First posted: 2017-10-26
Last updated: 2024-10-22
Results first posted: 2022-09-23

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	MTD/RP2D of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 28 days	The maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) will be the maximum dose at which fewer than one-third of patients experience dose limiting toxicities.
Primary	Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 3 years 8 months	Frequency of patients who experience at least one grade 3 or higher toxicity that is at least possibly attributable to pevonedistat using the Common Terminology Criteria for Adverse Events version 5.0 by dose level stratified by study part and dose level.
Primary	Half-life of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	Median (Range) for the time required for the serum concentration to fall to 50% of its starting dose by dose level stratified by study part and dose level.
Primary	T Max of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	Median (Range) for the time at which the maximum (peak) serum concentration occurs by dose level stratified by study part and dose level.
Primary	C Max of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	Median (Range) for the maximum (peak) serum concentration by dose level stratified by study part and dose level.
Primary	AUC of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	Median (range) of the area under the drug concentration over time (pre-dose and then 0, 1, 2, 4, 6-8, and 24-hours post-dose infusion) curve stratified by study part and dose level.
Primary	Clearance of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	Median (Range) for the rate of elimination of the drug by dose level stratified by study part and dose level.
Secondary	Anti-tumor Activity of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 4 years	Frequency of disease response (best overall response of partial or complete response) assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR by dose level.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	MTD/RP2D of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 28 days	All Part A patients	mg/m^2	NUMBER
PRIMARY	Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 3 years 8 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Half-life of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	All eligible patients with data collected	hours	MEDIAN
PRIMARY	T Max of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	All eligible patients with data collected	hours	MEDIAN
PRIMARY	C Max of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	All eligible patients with data collected	ng/mL	MEDIAN
PRIMARY	AUC of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	All eligible patients with data collected	hr*ng/mL	MEDIAN
PRIMARY	Clearance of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 10 days	All eligible patients with data collected	L/hr/m^2	MEDIAN
SECONDARY	Anti-tumor Activity of Pevonedistat in Combination With Irinotecan and Temozolomide	Up to 4 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group36

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

Outcome	Group	Value	Spread	Units
MTD/RP2D of Pevonedistat in Combination With Irinotecan and Temozolomide	Treatment (Pevonedistat, Temozolomide, Irinotecan)	35		mg/m^2
Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 1: 15 mg/m^2	5		Participants
Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 2: 20 mg/m^2	4		Participants
Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 3: 25 mg/m^2	6		Participants
Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 4: 35 mg/m^2	2		Participants
Number of Participants With Grade 3 or Greater Toxicities Associated With Pevonedistat in Combination With Irinotecan and Temozolomide	Part A PK Dose Level 4: 35 mg/m^2	4		Participants
Half-life of Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 1: 15 mg/m^2	5.3	Full Range 4.7 to 7.4	hours
Half-life of Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 2: 20 mg/m^2	5	Full Range 4.1 to 6.0	hours
Half-life of Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 3: 25 mg/m^2	5.2	Full Range 4.0 to 5.5	hours
Half-life of Pevonedistat in Combination With Irinotecan and Temozolomide	Part A Dose Level 4: 35 mg/m^2	4.7	Full Range 4.0 to 6.7	hours

1 to 10 of 36Source ClinicalTrials.gov

See all 36 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: 15 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 2: 20 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 3: 25 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 4: 35 mg/m^2	6
Overall Study	STARTED	Part A PK Dose Level 4: 35 mg/m^2	6
Overall Study	COMPLETED	Part A Dose Level 1: 15 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 2: 20 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 3: 25 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 4: 35 mg/m^2	0
Overall Study	COMPLETED	Part A PK Dose Level 4: 35 mg/m^2	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events1,120

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: 15 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 2: 20 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 3: 25 mg/m^2	1	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 4: 35 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part A PK Dose Level 4: 35 mg/m^2	0	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 1: 15 mg/m^2	2	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 2: 20 mg/m^2	2	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 3: 25 mg/m^2	3	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 4: 35 mg/m^2	0	6
other	Abdominal pain	Gastrointestinal disorders	Part A PK Dose Level 4: 35 mg/m^2	2	6

1 to 10 of 1,120Source ClinicalTrials.gov

See all 1,120 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: 15 mg/m^2	0	6
Total, all-cause mortality	Part A Dose Level 2: 20 mg/m^2	0	6
Total, all-cause mortality	Part A Dose Level 3: 25 mg/m^2	0	6
Total, all-cause mortality	Part A Dose Level 4: 35 mg/m^2	0	6
Total, all-cause mortality	Part A PK Dose Level 4: 35 mg/m^2	0	6
Total, other adverse events	Part A Dose Level 1: 15 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 2: 20 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 3: 25 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 4: 35 mg/m^2	6	6
Total, other adverse events	Part A PK Dose Level 4: 35 mg/m^2	6	6

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT03323034

GET https://conductscience.org/api/trials/v1/NCT03323034/results?page=2

API reference For AI assistants