Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057031
Status:
UNKNOWN
Last Update Posted:
2006-11-01
First Post:
2003-03-26
Brief Title:
Study of High-Dose Pulse Administration DN-101 Calcitriol in Patients With Myelodysplastic Syndrome MDS
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase 2 Multicenter Open Label Study of the Safety and Efficacy of High-Dose Pulse Administration DN-101 Calcitriol in Patients With Myelodysplastic Syndrome
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 purpose of this study is to determine the safety and efficacy of DN-101 calcitriol in patients with myelodysplastic syndrome who are dependent on repeat blood transfusions
Detailed Description:
DN-101 is an experimental drug that has not been approved by the 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 The natural vitamin D found in dairy products or in typical vitamin pills must be chemically changed by the liver and kidney into calcitriol before it is biologically active The body normally uses small amounts of calcitriol to regulate its blood calcium levels However for any possible therapeutic effect MDS patients require much higher levels of calcitriol than the body can produce from dietary vitamin D DN-101 provides MDS patients with high doses of calcitriol in a pill form
Laboratory studies have demonstrated evidence supporting the use of calcitriol in MDS High dose calcitriol slows the growth of leukemic cells cancerous cells and increases the growth of normal bone marrow cells Some patients with MDS may have low levels of calcitriol in their bone marrow
Clinical study results in patients with MDS have been mixed- some positive and some negative results Elevated calcium in the blood occurred frequently and prevented the use of higher more potentially therapeutic doses
Novacea tested a new formulation of calcitriol DN-101 in a Phase 1 study In that study the maximum tolerated dose of DN-101 that did not cause high blood calcium levels when given weekly for several months was determined That dose is within the range that is potentially therapeutic for MDS patients and will be used in this MDS study
The purposes of this study are to determine if HDPA DN-101 treatment
increases the number of red blood cells white blood cells and platelets in the blood
reduces the number of blood transfusions
reduces the number of serious infections requiring antibiotics
reduces the number of serious bleeding events
improves fatigue
Laboratory studies have demonstrated evidence supporting the use of calcitriol in MDS High dose calcitriol slows the growth of leukemic cells cancerous cells and increases the growth of normal bone marrow cells Some patients with MDS may have low levels of calcitriol in their bone marrow
Clinical study results in patients with MDS have been mixed- some positive and some negative results Elevated calcium in the blood occurred frequently and prevented the use of higher more potentially therapeutic doses
Novacea tested a new formulation of calcitriol DN-101 in a Phase 1 study In that study the maximum tolerated dose of DN-101 that did not cause high blood calcium levels when given weekly for several months was determined That dose is within the range that is potentially therapeutic for MDS patients and will be used in this MDS study
The purposes of this study are to determine if HDPA DN-101 treatment
increases the number of red blood cells white blood cells and platelets in the blood
reduces the number of blood transfusions
reduces the number of serious infections requiring antibiotics
reduces the number of serious bleeding events
improves fatigue
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