Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405574
Status:
UNKNOWN
Last Update Posted:
2008-01-30
First Post:
2006-11-29
Brief Title:
Study of ATN-224 in Patients With Prostate Cancer
Sponsor:
Attenuon
Organization:
Attenuon
Study Overview
Official Title:
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
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 ngmL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None