NCT01010126 · STUDY IN CONTEXT

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

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

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval).

All patients that received study treatment and were evaluated for response are included in this analysis

→

primary · POSTED

Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to \<1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort.

For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response.

→

secondary · POSTED

Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.

All patients that were assessed as a Complete Response or Partial Response were included in this analysis.

→

secondary · POSTED

Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.

All patients that received protocol treatment and were evaluated for adverse events are reported in this analysis.

→

secondary · POSTED

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.

All patients that received study intervention and were followed for survival were included in this analysis.

→

secondary · POSTED

Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.

All patients that began protocol treatment and were evaluated for response are included in this analysis.

→

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-advanced-hepatocellular-carcinoma
nct id: NCT01010126
trial label: Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
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: 6
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
source section id
NCT01010126-om-0000
source outcome index
0
endpoint
Progression Free Survival Rate
endpoint definition
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval).
time origin
6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients that received study treatment and were evaluated for response are included in this 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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
source section id
NCT01010126-om-0001
source outcome index
1
endpoint
Tumor Response Rate
endpoint definition
Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to \<1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort.
time origin
Up to 3 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response.
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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0002
source section id
NCT01010126-om-0002
source outcome index
2
endpoint
Duration of Response
endpoint definition
Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.
time origin
Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients that were assessed as a Complete Response or Partial Response were included in this 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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0003
source section id
NCT01010126-om-0003
source outcome index
3
endpoint
Incidence of Adverse Events
endpoint definition
Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.
time origin
Every cycle of treatment, up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients that received protocol treatment and were evaluated for adverse events are reported in this 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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0004
source section id
NCT01010126-om-0004
source outcome index
4
endpoint
Overall Survival
endpoint definition
Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.
time origin
Time from registration to death, assessed up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients that received study intervention and were followed for survival were included in this 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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0005
source section id
NCT01010126-om-0005
source outcome index
5
endpoint
Time to Disease Progression
endpoint definition
Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.
time origin
Time from registration to disease progression, assessed up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients that began protocol treatment and were evaluated for response are included in this 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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
arm key
OG000
arm label
Endometrial Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
arm key
OG001
arm label
Ovarian Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
arm key
OG002
arm label
Hepatocellular Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
arm key
OG003
arm label
Carcinoid Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
arm key
OG004
arm label
Islet Cell (Double Agent) Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0000
arm key
OG005
arm label
Islet Cell (Bevacizumab-only) Cohort
regimen
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
arm key
OG000
arm label
Endometrial Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
arm key
OG001
arm label
Ovarian Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
arm key
OG002
arm label
Hepatocellular Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
arm key
OG003
arm label
Carcinoid Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
57
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
arm key
OG004
arm label
Islet Cell (Double Agent) Cohort
regimen
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
outcome key
om-0001
arm key
OG005
arm label
Islet Cell (Bevacizumab-only) Cohort
regimen
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01010126-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-advanced-hepatocellular-carcinoma
nct id
NCT01010126
harm key
EG000
source section id
NCT01010126-ae
event group key
EG000
event group label
Endometrial Cohort
serious affected
16
serious at risk
26
other affected
26
other at risk
26
frequency threshold
0
collection period
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
event definition
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
harm key
EG001
source section id
NCT01010126-ae
event group key
EG001
event group label
Ovarian Cohort
serious affected
34
serious at risk
58
other affected
58
other at risk
58
frequency threshold
0
collection period
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
event definition
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
harm key
EG002
source section id
NCT01010126-ae
event group key
EG002
event group label
Hepatocellular Cohort
serious affected
13
serious at risk
27
other affected
27
other at risk
27
frequency threshold
0
collection period
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
event definition
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
harm key
EG003
source section id
NCT01010126-ae
event group key
EG003
event group label
Carcinoid Cohort
serious affected
36
serious at risk
57
other affected
56
other at risk
57
frequency threshold
0
collection period
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
event definition
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
harm key
EG004
source section id
NCT01010126-ae
event group key
EG004
event group label
Islet Cell (Double Agent) Cohort
serious affected
27
serious at risk
55
other affected
55
other at risk
55
frequency threshold
0
collection period
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
event definition
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
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-advanced-hepatocellular-carcinoma
nct id
NCT01010126
harm key
EG005
source section id
NCT01010126-ae
event group key
EG005
event group label
Islet Cell (Bevacizumab-only) Cohort
serious affected
6
serious at risk
24
other affected
24
other at risk
24
frequency threshold
0
collection period
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
event definition
Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
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