NCT01553539 · STUDY IN CONTEXT

Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery

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

'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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.

Source null

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primary · POSTED

See the adverse event tables for specifics.

Source null

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secondary · POSTED

Time to Disease Progression

Source null

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secondary · POSTED

Overall Survival

Source null

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secondary · POSTED

Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)

Source null

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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

FACT · Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-osteosarcoma-recurrent-90acb206
nct id: NCT01553539
qol key: qol-0004
source section id: NCT01553539-om-0004
source outcome index: 4
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
measure definition: Source null
time frame: Baseline and Day 22
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-osteosarcoma-recurrent-90acb206
nct id: NCT01553539
trial label: Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
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: 5
harms Count: 1
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0000
source section id
NCT01553539-om-0000
source outcome index
0
endpoint
Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
endpoint definition
'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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.
time origin
Approximately 1 year
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-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0001
source section id
NCT01553539-om-0001
source outcome index
1
endpoint
Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
endpoint definition
See the adverse event tables for specifics.
time origin
Approximately 1 year
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-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0002
source section id
NCT01553539-om-0002
source outcome index
2
endpoint
Time to Disease Progression
endpoint definition
Time to Disease Progression
time origin
Approximately 5 years
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-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0003
source section id
NCT01553539-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Overall Survival
time origin
Approximately 5 years
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-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0004
source section id
NCT01553539-om-0004
source outcome index
4
endpoint
Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
endpoint definition
Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
time origin
Baseline and Day 22
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

arms

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0000
arm key
OG000
arm label
Treatment (Antiangiogenesis Therapy)
regimen
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01553539-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0001
arm key
OG000
arm label
Treatment (Antiangiogenesis Therapy)
regimen
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01553539-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0002
arm key
OG000
arm label
Treatment (Antiangiogenesis Therapy)
regimen
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01553539-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0003
arm key
OG000
arm label
Treatment (Antiangiogenesis Therapy)
regimen
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01553539-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
outcome key
om-0004
arm key
OG000
arm label
Treatment (Antiangiogenesis Therapy)
regimen
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01553539-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
harm key
EG000
source section id
NCT01553539-ae
event group key
EG000
event group label
Treatment (Antiangiogenesis Therapy)
serious affected
11
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
collection period
Duration of treatment, up to one year
event definition
worst of each type of adverse event was recorded for each patient
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

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT01553539
qol key
qol-0004
source section id
NCT01553539-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
measure definition
Source null
time frame
Baseline and Day 22
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice