Study of ATN-224 in Patients With Prostate Cancer
- Registration Number
- NCT00405574
- Lead Sponsor
- Attenuon
- Brief Summary
This is a multicenter, randomized, phase II study of the safety and efficacy of two dose levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the absence of detectable disease. Patients will be randomized (1:1) after confirmation of eligibility requirements. The primary endpoint is to determine the proportion of patients who do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50% increase in PSA and \>5 ng/mL from baseline or post-treatment nadir if lower than baseline, confirmed by another PSA at least 28 days later.
- Detailed Description
ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be anti-angiogenic and to have activity against prostate cancer cell lines. ATN-224 has the potential to affect the progression of prostate cancer by mechanisms that include both antiangiogenic and antitumor pathways. ATN-224 may change the time to overt metastatic disease in patients with rising PSA as the only manifestation of disease after treatment with curative intent and delay the need for hormonal therapies.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose ATN-224 ATN-224 dose 300mg Low Dose ATN-224 ATN-224 dose: 30mg
- Primary Outcome Measures
Name Time Method Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks 24 weeks
- Secondary Outcome Measures
Name Time Method Establish the safety of the two dose levels of ATN-224 Ongoing Determine the proportion of patients with a 50% reduction from baseline of PSA confirmed by a second PSA value at least 28 days later End of Study Determine the change in PSA doubling time (PSA-DT) from baseline End of Study Determine the maximal % decrease in PSA after treatment End of Study Determine the time to PSA progression (as defined by this protocol) End of Study Determine the 24-week rate of metastases 24 weeks Determine the effect of ATN-224 treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red blood cells End of Study
Trial Locations
- Locations (6)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States