Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043576
Status:
UNKNOWN
Last Update Posted:
2009-03-12
First Post:
2002-08-09
Brief Title:
ASCENT Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase 23 Multicenter Randomized Double Blind Study of Docetaxel Taxotere Plus DN-101 or Placebo in Androgen Independent Prostate Cancer AIPC
Status:
UNKNOWN
Status Verified Date:
2005-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels delays or limits disease progression and is safe with minimal side effects
Detailed Description:
DN-101 is an investigational drug that has not been approved by the US Food and Drug Administration FDA It is a newly formulated pill that contains high amounts of calcitriol a naturally occurring hormone and the biologically active form of vitamin D Administration of DN-101 results in much higher blood levels of calcitriol than the body can produce from dietary vitamin D or vitamin D supplements These higher levels of calcitriol are associated with anti-cancer effects in laboratory models of human cancer Laboratory models also indicate that calcitriol has synergy with many commonly used chemotherapeutic agents used to treat cancer
Calcitriol at very low doses is currently approved for use in patients with chronic kidney failure DN-101 was specifically designed for cancer and contains 30 times the amount of calcitriol found in the calcitriol pill commercially available today In order to take an amount of calcitriol equivalent to 1 DN-101 pill cancer patients would need to swallow 30 pills of the approved low dose formulation DN-101 represents a breakthrough in the use of calcitriol in the clinic because it contains high concentrations of calcitriol and makes it more feasible for patients to stay on regimen
Calcitriol at very low doses is currently approved for use in patients with chronic kidney failure DN-101 was specifically designed for cancer and contains 30 times the amount of calcitriol found in the calcitriol pill commercially available today In order to take an amount of calcitriol equivalent to 1 DN-101 pill cancer patients would need to swallow 30 pills of the approved low dose formulation DN-101 represents a breakthrough in the use of calcitriol in the clinic because it contains high concentrations of calcitriol and makes it more feasible for patients to stay on regimen
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ASCENT Trial | None | None | None |