|
|
Active Trials: ATN-224
| Protocol
ATN-224-005 (Prostate Cancer) |
| Protocol
Title |
A Randomized,
Phase II Study of Two Dose Levels of ATN-224 in Patients With
Biochemically Relapsed, Hormone-naïve Prostate Cancer |
| Objectives |
Primary
- In patients with biochemically relapsed, hormone-naïve prostate cancer, determine the proportion who have not had prostate specific antigen (PSA) progression at 24 weeks for two dose levels of ATN-224. The
lower dose level (30 mg) is hypothesized to be antiangiogenic and
the higher dose level (300 mg) is hypothesized to have direct
anti-tumor activity.
Secondary
- Establish the safety of
the two dose levels of ATN-224
- For each dose
level, determine:
- Proportion of patients
with a 50% reduction from baseline of PSA confirmed by a second PSA
value at least 28 days later
- Change in PSA doubling
time (PSA-DT) from baseline
- Maximal % decrease in
PSA after treatment
- Time to PSA progression
(as defined by this protocol)
- 24-week rate of
metastases
- Effect of ATN-224
treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red
blood cells
|
| Patient
Population |
Patients With
Biochemically Relapsed, Hormone-naïve Prostate Cancer |
| Study Status |
Recruiting |
Click here to view current investigational sites at www.clinicaltrials.gov
|
|