NCT01653028 · STUDY IN CONTEXT

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.

Source null

→

secondary · POSTED

The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).

Source null

→

secondary · POSTED

The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).

Source null

→

secondary · POSTED

Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.

All patients that began study treatment were assessed for this endpoint.

→

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-leiomyosarcoma
nct id: NCT01653028
trial label: Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 4
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0000
source section id
NCT01653028-om-0000
source outcome index
0
endpoint
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.
endpoint definition
The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.
time origin
Up to 18 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0001
source section id
NCT01653028-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).
time origin
The time between registration and death, assessed up to 18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0002
source section id
NCT01653028-om-0002
source outcome index
2
endpoint
Progression Free Survival (PFS)
endpoint definition
The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).
time origin
The time between registration to disease progression or death, assessed up to 18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0003
source section id
NCT01653028-om-0003
source outcome index
3
endpoint
Adverse Events
endpoint definition
Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
time origin
During treatment and up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients that began study treatment were assessed for this endpoint.
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-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0000
arm key
OG000
arm label
Cohort 1
regimen
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0000
arm key
OG001
arm label
Cohort 2
regimen
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0000
arm key
OG002
arm label
Cohort 3
regimen
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0000
arm key
OG003
arm label
Cohort 4
regimen
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0000
arm key
OG004
arm label
Cohort 5
regimen
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0001
arm key
OG000
arm label
Cohort 1
regimen
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0001
arm key
OG001
arm label
Cohort 2
regimen
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0001
arm key
OG002
arm label
Cohort 3
regimen
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0001
arm key
OG003
arm label
Cohort 4
regimen
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0001
arm key
OG004
arm label
Cohort 5
regimen
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0002
arm key
OG000
arm label
Cohort 1
regimen
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
outcome key
om-0002
arm key
OG001
arm label
Cohort 2
regimen
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01653028-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-leiomyosarcoma
nct id
NCT01653028
harm key
EG000
source section id
NCT01653028-ae
event group key
EG000
event group label
Cohort 1
serious affected
2
serious at risk
12
other affected
12
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-leiomyosarcoma
nct id
NCT01653028
harm key
EG001
source section id
NCT01653028-ae
event group key
EG001
event group label
Cohort 2
serious affected
2
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-leiomyosarcoma
nct id
NCT01653028
harm key
EG002
source section id
NCT01653028-ae
event group key
EG002
event group label
Cohort 3
serious affected
1
serious at risk
11
other affected
11
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-leiomyosarcoma
nct id
NCT01653028
harm key
EG003
source section id
NCT01653028-ae
event group key
EG003
event group label
Cohort4
serious affected
4
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-leiomyosarcoma
nct id
NCT01653028
harm key
EG004
source section id
NCT01653028-ae
event group key
EG004
event group label
Cohort 5
serious affected
13
serious at risk
29
other affected
28
other at risk
29
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