A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas
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.
I. To assess time to progression (TTP) and overall survival (OS) in patients treated with
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).
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Antitumor activity as assessed by objective tumor response
'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. 95% Confidence Intervals will be estimated. Fisher's exact and t-tests or Wilcoxon rank-sum tests used to assess the univariate associations of patient characteristics with response. Logistic regression used to determine which covariates are jointly predictive of response.
Approximately 1 year
Wake Forest University
United States: Food and Drug Administration
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|