NCT01154816 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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.

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secondary · POSTED

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.

116 patients contributed 360 patient-cycles to the analysis.

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secondary · POSTED

Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.

Of all eligible patients enrolled, 32 provided a prior to the first day of administration sample for analysis.

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secondary · POSTED

Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.

Of all eligible patients enrolled, 16 provided a first day of administration one hour after administration infusion sample for analysis.

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secondary · POSTED

Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.

Of all eligible patients enrolled, 16 provided a first day of administration three hours after administration sample for analysis.

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secondary · POSTED

Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.

Of all eligible patients enrolled, 16 provided a first day of administration six hours after administration sample for analysis.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id: NCT01154816
trial label: Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 12
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
source section id
NCT01154816-om-0000
source outcome index
0
endpoint
Number of Participants With Overall Response
endpoint definition
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.
time origin
From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0001
source section id
NCT01154816-om-0001
source outcome index
1
endpoint
Number of Patients Cycles With Grade 3 or Higher Adverse Event
endpoint definition
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.
time origin
Up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
116 patients contributed 360 patient-cycles to the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0002
source section id
NCT01154816-om-0002
source outcome index
2
endpoint
Serum Concentration of Alisertib Prior to the First Day of Administration
endpoint definition
Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.
time origin
day 1 of protocol therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of all eligible patients enrolled, 32 provided a prior to the first day of administration sample for analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0003
source section id
NCT01154816-om-0003
source outcome index
3
endpoint
Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration
endpoint definition
Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.
time origin
day 1 of protocol therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of all eligible patients enrolled, 16 provided a first day of administration one hour after administration infusion sample for analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0004
source section id
NCT01154816-om-0004
source outcome index
4
endpoint
Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration
endpoint definition
Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.
time origin
day 1 of protocol therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of all eligible patients enrolled, 16 provided a first day of administration three hours after administration sample for analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0005
source section id
NCT01154816-om-0005
source outcome index
5
endpoint
Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration
endpoint definition
Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.
time origin
day 1 of protocol therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of all eligible patients enrolled, 16 provided a first day of administration six hours after administration sample for analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG000
arm label
Recurrent Neuroblastoma With Measurable Disease at Enrollment
regimen
Experimental: Arm 1
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG001
arm label
Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll
regimen
Experimental: Arm 2
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG002
arm label
Previously Treated Childhood Rhabdomyosarcoma
regimen
Experimental: Arm 3
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG003
arm label
Recurrent Osteosarcoma
regimen
Experimental: Arm 4
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG004
arm label
Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor
regimen
Experimental: Arm 5
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG005
arm label
Recurrent Childhood Soft Tissue Sarcoma
regimen
Experimental: Arm 6
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG006
arm label
Childhood Hepatoblastoma
regimen
Experimental: Arm 7
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG007
arm label
Recurrent Childhood Germ Cell Tumor
regimen
Experimental: Arm 8
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG008
arm label
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
regimen
Experimental: Arm 9
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG009
arm label
Recurrent Childhood Acute Lympohblastic Leukemia
regimen
Experimental: Arm 10
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG010
arm label
Recurrent Childhood Acute Myeloid Leukemia
regimen
Experimental: Arm 11
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
outcome key
om-0000
arm key
OG011
arm label
Rhaboid Malignancy
regimen
Experimental: Arm 12
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01154816-om-0000#groups/OG011

harms

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG000
source section id
NCT01154816-ae
event group key
EG000
event group label
Recurrent Neuroblastoma With Measurable Disease at Enrollment
serious affected
7
serious at risk
20
other affected
15
other at risk
20
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG001
source section id
NCT01154816-ae
event group key
EG001
event group label
Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll
serious affected
5
serious at risk
12
other affected
11
other at risk
12
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG002
source section id
NCT01154816-ae
event group key
EG002
event group label
Previously Treated Childhood Rhabdomyosarcoma
serious affected
4
serious at risk
10
other affected
8
other at risk
10
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG003
source section id
NCT01154816-ae
event group key
EG003
event group label
Recurrent Osteosarcoma
serious affected
7
serious at risk
10
other affected
9
other at risk
10
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG004
source section id
NCT01154816-ae
event group key
EG004
event group label
Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor
serious affected
5
serious at risk
10
other affected
9
other at risk
10
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG005
source section id
NCT01154816-ae
event group key
EG005
event group label
Recurrent Childhood Soft Tissue Sarcoma
serious affected
3
serious at risk
8
other affected
6
other at risk
8
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG006
source section id
NCT01154816-ae
event group key
EG006
event group label
Childhood Hepatoblastoma
serious affected
6
serious at risk
6
other affected
3
other at risk
6
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG007
source section id
NCT01154816-ae
event group key
EG007
event group label
Recurrent Childhood Germ Cell Tumor
serious affected
1
serious at risk
7
other affected
5
other at risk
7
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG008
source section id
NCT01154816-ae
event group key
EG008
event group label
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
serious affected
3
serious at risk
10
other affected
9
other at risk
10
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG009
source section id
NCT01154816-ae
event group key
EG009
event group label
Recurrent Childhood Acute Lympohblastic Leukemia
serious affected
8
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG010
source section id
NCT01154816-ae
event group key
EG010
event group label
Recurrent Childhood Acute Myeloid Leukemia
serious affected
5
serious at risk
11
other affected
9
other at risk
11
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01154816
harm key
EG011
source section id
NCT01154816-ae
event group key
EG011
event group label
Rhaboid Malignancy
serious affected
2
serious at risk
4
other affected
2
other at risk
4
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice