Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480090
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2007-05-28
Brief Title:
A Phase II Study of Ara-C Cytarabine in Men With Androgen Independent Prostate Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of Ara-C Cytarabine in Men With Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
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:
SLAP
Brief Summary:
This is a single-arm open label phase II trial of the investigational agent Ara-C cytarabine in patients diagnosed with hormone refractory prostate cancer whose disease has progressed on or deemed not suitable for standard chemotherapy with docetaxel Ara-C appears to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells Recent discoveries have suggested the role of gene fusions in the ETS family of transcription factors as important for the development of prostate cancer Ara-C appears to block ETS genes suggesting that it is worthwhile to explore Ara-C as a potential new treatment for patients with hormone refractory prostate cancer given that there is no standard of care for the proposed patient population In this study Ara-C will be administered intravenously for 2 days every 3 weeks 1 cycle Treatment will be for 6 cycles if tolerated and may be continued in patients who are responding and do not have severe toxicity
Detailed Description:
None
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