A Randomized, Phase II Study of Two Dose Levels of ATN-224 in Patients With Biochemically Relapsed, Early Stage Prostate Cancer Not on Hormone Therapy
Overview
- Phase
- Phase 2
- Intervention
- ATN-224
- Conditions
- Prostate Cancer
- Sponsor
- Attenuon
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
High Dose
ATN-224 dose 300mg
Intervention: ATN-224
Low Dose
ATN-224 dose: 30mg
Intervention: ATN-224
Outcomes
Primary Outcomes
Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
Time Frame: 24 weeks
Secondary Outcomes
- 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)