Clinical trial · Interventional
Angiotensin-(1-7) in Treating Patients With Metastatic or Unresectable Solid Tumors
Phase I Clinical Trial of Angiotensin 1-7 for Advanced Solid Tumors
NCT00471562CI-TRIAL-00028874completedPhase 1ClinicalTrials.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)
RATIONALE: Angiotensin-(1-7) may stop the growth of solid tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of angiotensin-(1-7) in treating patients with metastatic or unresectable solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic angiotensin-(1-7) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- 21 days
- measure
- Toxicity
- timeFrame
- 105 days
Secondary outcomes (1)
- measure
- Response rate (complete or partial response) as measured by RECIST criteria
- timeFrame
- 105 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed advanced solid tumor meeting 1 of the following criteria:
* Metastatic disease
* Unresectable disease
* Standard curative or palliative measures do not exist or are no longer effective
* Measurable or nonmeasurable disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* Nonmeasurable disease, defined as all other lesions, including small lesions (i.e., ≥ 1 unidimensionally measurable lesion \< 20 mm by conventional techniques or \< 10 mm by spiral CT scan) and truly nonmeasurable lesions, including any of the following:
* Bone lesions
* Ascites
* Pleural or pericardial effusion
* Lymphangitis cutis or pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* No lung cancer with recent hemoptysis
* No brain metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 4 weeks
* No evidence of bleeding diathesis
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine clearance \> 30 mL/min
* Bilirubin \< 2 mg/dL
* AST and ALT \< 3 times upper limit of normal
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Uncontrolled hypertension or hypotension
* No psychiatric illness or social situation that would preclude informed consent or study compliance
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior major surgery
* At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for melphalan, nitrosoureas, or mitomycin C)
* No concurrent therapeutic anticoagulation
* No other concurrent investigational agents
* No concurrent angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers
* No concurrent combination antiretroviral therapy for HIV-positive patientsReferences
Publications (1)
- RESULTPetty WJ, Miller AA, McCoy TP, Gallagher PE, Tallant EA, Torti FM. Phase I and pharmacokinetic study of angiotensin-(1-7), an endogenous antiangiogenic hormone. Clin Cancer Res. 2009 Dec 1;15(23):7398-404. doi: 10.1158/1078-0432.CCR-09-1957. Epub 2009 Nov 17. PMID 19920106