Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055263
Status:
COMPLETED
Last Update Posted:
2009-07-28
First Post:
2003-02-21
Brief Title:
A New Formulation of Calcitriol DN-101 in Patients With Advanced Malignancies
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase I Open Label Dose Escalation Study of a New Formulation of Calcitriol DN-101 for Safety Tolerability and Pharmacokinetics in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2003-02
Last Known Status:
None
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
Test the safety of DN-101 in patients with advanced malignancies
Understand how fast the body absorbs processes and eliminates DN-101
Determine the highest dose of DN-101 that is well tolerated by cancer patients
Learn how fast the body absorbs processes and eliminates DN-101 compared to the approved product
Test the safety of DN-101 in patients with advanced malignancies
Understand how fast the body absorbs processes and eliminates DN-101
Determine the highest dose of DN-101 that is well tolerated by cancer patients
Learn how fast the body absorbs processes and eliminates DN-101 compared to the approved product
Detailed Description:
Calcitriol at low doses is approved by the FDA for use in patients with chronic renal failure However much higher doses of calcitriol are needed for any possible anti-cancer effect DN-101 is a new capsule that contains 30 times the amount of calcitriol found in the currently available calcitriol capsule In order to take an amount of calcitriol equivalent to 1 capsule of DN-101 cancer patients would need to swallow 30 pills of the approved low dose formulation
DN-101 is a pill containing calcitriol a chemical related to vitamin D that is immediately active in your body The natural vitamin D found in dairy products or in typical vitamin pills must be chemically changed by your liver and kidney into calcitriol before it is active High doses of calcitriol had anti-cancer effects when tested in animals DN-101 may have anticancer effects in your kind of cancer
DN-101 is a pill containing calcitriol a chemical related to vitamin D that is immediately active in your body The natural vitamin D found in dairy products or in typical vitamin pills must be chemically changed by your liver and kidney into calcitriol before it is active High doses of calcitriol had anti-cancer effects when tested in animals DN-101 may have anticancer effects in your kind of cancer
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