Clinical trial · Interventional
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas
NCT01553539CI-TRIAL-00033610completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cancer | Malignant Bone Neoplasm | ALIAS | 0.90 |
| Chondrosarcoma | Chondrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Sarcoma of the Kidney | Clear Cell Sarcoma of the Kidney | ONTOLOGY_EXACT | 0.98 |
| Metastatic Osteosarcoma | Osteosarcoma | CURATED_BROADER | 0.78 |
| Ovarian Sarcoma | Ovarian Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Recurrent Osteosarcoma | Osteosarcoma | CURATED_BROADER | 0.78 |
| Recurrent Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic angiotensin-(1-7) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (antiangiogenesis therapy)
- description
- Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: therapeutic angiotensin-(1-7)
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
- timeFrame
- Approximately 1 year
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.