Trial · NCT01154816

Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

NCT01154816, Phase 2, Completed, Children's Oncology Group; results first posted 2017-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia. Trials, record NCT01154816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154816

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Trial

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

Title: Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
NCT number: NCT01154816
Status: Completed
Phases: Phase 2
Enrollment: 118 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Hepatoblastoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Kidney Neoplasm, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma
Interventions: Alisertib, Laboratory Biomarker Analysis, Pharmacological Study
First posted: 2010-07-01
Last updated: 2020-05-13
Results first posted: 2017-06-05

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Overall Response	From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.	For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with \< 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.
Secondary	Number of Patients Cycles With Grade 3 or Higher Adverse Event	Up to 24 months	The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.
Secondary	Serum Concentration of Alisertib Prior to the First Day of Administration	day 1 of protocol therapy	Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.
Secondary	Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration	day 1 of protocol therapy	Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.
Secondary	Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration	day 1 of protocol therapy	Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.
Secondary	Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration	day 1 of protocol therapy	Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.
Secondary	Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose	day 4 of protocol therapy	Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter.
Secondary	Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.	day 7 of protocol therapy	Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter.

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	Number of Participants With Overall Response	From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.	Of the 118 enrolled patients, two were not evaluable for the primary outcome measure. Neither received protocol therapy. One was enrolled in arm 11, one was enrolled in Arm 1.	Patients	NUMBER
SECONDARY	Number of Patients Cycles With Grade 3 or Higher Adverse Event	Up to 24 months	116 patients contributed 360 patient-cycles to the analysis.	Patient-cycle	NUMBER
SECONDARY	Serum Concentration of Alisertib Prior to the First Day of Administration	day 1 of protocol therapy	Of all eligible patients enrolled, 32 provided a prior to the first day of administration sample for analysis.	ng/ml	MEAN
SECONDARY	Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration	day 1 of protocol therapy	Of all eligible patients enrolled, 16 provided a first day of administration one hour after administration infusion sample for analysis.	ng/ml	MEAN
SECONDARY	Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration	day 1 of protocol therapy	Of all eligible patients enrolled, 16 provided a first day of administration three hours after administration sample for analysis.	ng/ml	MEAN
SECONDARY	Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration	day 1 of protocol therapy	Of all eligible patients enrolled, 16 provided a first day of administration six hours after administration sample for analysis.	ng/ml	MEAN
SECONDARY	Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose	day 4 of protocol therapy	Of all eligible patients enrolled, 30 provided a fourth day of administration prior to the administration of the day 4 dose sample for analysis.	ng/ml	MEAN
SECONDARY	Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.	day 7 of protocol therapy	Of all eligible patients enrolled, 31 provided a seventh day of administration prior to the administration of the day 7 dose sample for analysis.	ng/ml	MEAN

Source ClinicalTrials.gov

Results by group88

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

Outcome	Group	Value	Units
Number of Participants With Overall Response	Recurrent Neuroblastoma With Measurable Disease at Enrollment	0	Patients
Number of Participants With Overall Response	Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll	1	Patients
Number of Participants With Overall Response	Previously Treated Childhood Rhabdomyosarcoma	0	Patients
Number of Participants With Overall Response	Recurrent Osteosarcoma	0	Patients
Number of Participants With Overall Response	Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor	0	Patients
Number of Participants With Overall Response	Recurrent Childhood Soft Tissue Sarcoma	0	Patients
Number of Participants With Overall Response	Childhood Hepatoblastoma	0	Patients
Number of Participants With Overall Response	Recurrent Childhood Germ Cell Tumor	0	Patients
Number of Participants With Overall Response	Recurrent Wilms Tumor and Other Childhood Kidney Tumors	1	Patients
Number of Participants With Overall Response	Recurrent Childhood Acute Lympohblastic Leukemia	0	Patients

1 to 10 of 88Source ClinicalTrials.gov

See all 88 results by group

Participant flow36

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Recurrent Neuroblastoma With Measurable Disease at Enrollment	20
Overall Study	STARTED	Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll	12
Overall Study	STARTED	Previously Treated Childhood Rhabdomyosarcoma	10
Overall Study	STARTED	Recurrent Osteosarcoma	10
Overall Study	STARTED	Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor	10
Overall Study	STARTED	Recurrent Childhood Soft Tissue Sarcoma	8
Overall Study	STARTED	Childhood Hepatoblastoma	6
Overall Study	STARTED	Recurrent Childhood Germ Cell Tumor	7
Overall Study	STARTED	Recurrent Wilms Tumor and Other Childhood Kidney Tumors	10
Overall Study	STARTED	Recurrent Childhood Acute Lympohblastic Leukemia	10

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events1,980

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	Recurrent Neuroblastoma With Measurable Disease at Enrollment	0	20
other	Abdominal distension	Gastrointestinal disorders	Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll	0	12
other	Abdominal distension	Gastrointestinal disorders	Previously Treated Childhood Rhabdomyosarcoma	0	10
other	Abdominal distension	Gastrointestinal disorders	Recurrent Osteosarcoma	1	10
other	Abdominal distension	Gastrointestinal disorders	Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor	0	10
other	Abdominal distension	Gastrointestinal disorders	Recurrent Childhood Soft Tissue Sarcoma	0	8
other	Abdominal distension	Gastrointestinal disorders	Childhood Hepatoblastoma	0	6
other	Abdominal distension	Gastrointestinal disorders	Recurrent Childhood Germ Cell Tumor	0	7
other	Abdominal distension	Gastrointestinal disorders	Recurrent Wilms Tumor and Other Childhood Kidney Tumors	0	10
other	Abdominal distension	Gastrointestinal disorders	Recurrent Childhood Acute Lympohblastic Leukemia	0	10

1 to 10 of 1,980Source ClinicalTrials.gov

See all 1,980 adverse events

Adverse event totals36

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Recurrent Neuroblastoma With Measurable Disease at Enrollment
Total, all-cause mortality	Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll
Total, all-cause mortality	Previously Treated Childhood Rhabdomyosarcoma
Total, all-cause mortality	Recurrent Osteosarcoma
Total, all-cause mortality	Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor
Total, all-cause mortality	Recurrent Childhood Soft Tissue Sarcoma
Total, all-cause mortality	Childhood Hepatoblastoma
Total, all-cause mortality	Recurrent Childhood Germ Cell Tumor
Total, all-cause mortality	Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Total, all-cause mortality	Recurrent Childhood Acute Lympohblastic Leukemia

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30777875	DERIVED	PubMed
34435684	DERIVED	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
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

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/NCT01154816

GET https://conductscience.org/api/trials/v1/NCT01154816/results?page=2

API reference For AI assistants