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← Osteosarcoma

NCT01553539 · STUDY IN CONTEXT

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

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

'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

→

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