NCT01553539 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-07-05

This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor. Funding Source - FDA Office of Orphan Drug Products (OOPD)

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response

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outcome · POSTED

Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

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outcome · POSTED

Time to Disease Progression

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outcome · POSTED

Overall Survival

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients must have a histologically or cytologically confirmed sarcoma that is metastatic or unresectable and have progressed despite 1 or 2 prior treatment regimens with chemotherapy or targeted anti-cancer agents such as imatinib * Prior treatment: \>= 4 weeks since completion of radiation or chemotherapy, except for \>= 6 weeks for Melphalan, nitrosoureas, or mitomycin-C * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count \>= 1,500/Microliter (mcL) * Platelets \>= 100,000/mcL * Total bilirubin =\< 2 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 3 X upper limit or normal (ULN) * Estimated (est.) creatinine clearance \> 30 mL/min * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as \> 10 mm * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients may not be receiving any other investigational agents for cancer treatment * Patients with evidence of bleeding diathesis are ineligible * No concurrent treatment with angiotensin-converting-enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or hypotension, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and nursing women are excluded from this study
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: therapeutic angiotensin-(1-7)
Other: laboratory biomarker analysis
label
Treatment (antiangiogenesis therapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (antiangiogenesis therapy)
description
Given SC
name
therapeutic angiotensin-(1-7)
other Names
therapeutic Ang-(1-7)
TXA127
type
DRUG
arm Group Labels
Treatment (antiangiogenesis therapy)
description
Correlative study
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 20
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
'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.
measure
Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
time Frame
Approximately 1 year
description
See the adverse event tables for specifics.
measure
Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
time Frame
Approximately 1 year

secondary Outcomes

measure
Time to Disease Progression
time Frame
Approximately 5 years
measure
Overall Survival
time Frame
Approximately 5 years
measure
Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)
time Frame
Baseline and Day 22

Full study description

brief Summary: This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor. Funding Source - FDA Office of Orphan Drug Products (OOPD)
detailed Description: PRIMARY OBJECTIVES: I. To evaluate the response rate of chemotherapy-refractory sarcomas to 20 mg per day of single-agent Ang(Angiotensin)-(1-7) or 10 mg per day of single-agent Ang-(1-7) if excessive toxicity is observed at the 20 mg dose. II. To evaluate toxicities associated with single-agent Ang-(1-7) when given to patients with chemotherapy-refractory sarcomas. SECONDARY OBJECTIVES: I. To assess time to progression (TTP) and overall survival (OS) in patients treated with Ang-(1-7). II. To evaluate accumulation of Ang-(1-7) after 21 days of continuous treatment and quantify changes in plasma levels of angiogenic peptides including placental growth factor (PlGF). OUTLINE: Patients receive therapeutic angiotensin-(1-7) subcutaneously (SC) once daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-db009050943414008712
requested nct id
NCT01553539
primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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payload
clinical indication matching status
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true
id
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link basis
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nct id
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occurrences
context exact
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end
11
exact text
NCT01553539
start
0
offset unit
unicode_code_points
query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
source file sha256
21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
source json pointer
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source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
b7b39eb91c25d1dea188fd86caeb91c0e82dbff2e28d997dcd4c9511d9a156c1
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice