NCT00405574

Study of ATN-224 in Patients With Prostate Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Attenuon · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ATN-224	ATN-224 high dose: 300mg ATN-224 low dose: 30mg

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2006-11-30
• Last updated: 2008-01-30

Locations

6 sites across 1 country: United States