Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113893
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2005-06-10
Brief Title:
SCIO-469 Open-Label Study for Patients With Myelodysplastic Syndromes
Sponsor:
Scios Inc
Organization:
Scios Inc
Study Overview
Official Title:
A Randomized MultiCenter Open-Label Modified Dose-Ascension Parallel Study of the Safety Tolerability and Efficacy of Oral SCIO-469 in Patients With Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2013-10
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:
None
Brief Summary:
The purpose of this study is to determine the safety and effectiveness of oral SCIO-469 in patients with myelodysplastic syndromes SCIO-469 belongs to a new class of treatments that inhibit expression and activity of cytokines that play a role in the progression of MDS
Detailed Description:
SCIO-469 belongs to a new class of treatment that inhibits p38 MAP kinase p38 MAPK activation controls the production of TNF-a VEGF and IL-1b As an inhibitor of p38 MAPK SCIO-469 blocks the synthesis of these molecules as well as TNF-a activity This randomized open-label modified dose-ascension study is designed to assess the safety tolerability and efficacy of oral SCIO-469 in the treatment of patients with MDS This patient group was selected because of the inhibitory effect of SCIO-469 on the expression and activity of cytokines that play a role in the progression of MDS The treatment arms will be 30 60 90 or 120 mg tid with 15 subjects per arm total of 60 subjects and each arm may expand to 25 subjects per arm maximum total of 100 subjects Initially subjects will be randomly assigned to one of the lowest two treatment arms 30 mg tid or 60 mg tid When 6 subjects per arm at least 12 subjects total have received study drug for at least 4 weeks predefined criteria will be used to determine whether to open randomization into the third arm ie 90 mg tid The criteria will be based on the number of subjects who have had to suspend study drug due to drug-related toxicity The 120-mg tid arm will be open for enrollment after 15 subjects have been enrolled into each of the first three treatment arms the decision to open enrollment will be similar to the criteria used to open the third arm Subjects will be evaluated at least monthly for safety and some efficacy measurements AE reporting safety labs and vitals Subjects will receive study drug for 16 weeks Subjects who demonstrate hematologic improvement erythroid platelet or neutrophil response by IWG criteria at week 16 will be eligible to continue treatment at the same dose of study drug for up to 36 additional weeks 52 weeks of total drug exposure Subjects who do not meet the IWG criteria for hematologic improvement at week 16 but who in the judgment of the investigator experience clinical benefit may also receive up to 36 additional weeks of treatment The same judgments for treatment extensions of additional 26 weeks in responding subjects will be made at 52 weeks and 78 weeks maximum total drug exposure will be 104 weeks All subjects will be followed for 4 weeks after the last study drug treatment for safety assessments or until resolution of Grade 3 or greater treatment-related toxicity as defined by NCI CTCAE v 30
Oral SCIO-469 given for 16 weeks to patients with MDS Subjects will receive a total daily dose of SCIO-469 of 90 mg 180 mg 270 mg or 360 mg The treatment arms will be 30-mg tablet tid 60-mg tablet tid 90-mg tablet tid or 120 mg ie two 60-mg tablets tid with 15 subjects per arm total of 60 subjects Responding subjects may dose for up to 104 weeks total drug exposure
Oral SCIO-469 given for 16 weeks to patients with MDS Subjects will receive a total daily dose of SCIO-469 of 90 mg 180 mg 270 mg or 360 mg The treatment arms will be 30-mg tablet tid 60-mg tablet tid 90-mg tablet tid or 120 mg ie two 60-mg tablets tid with 15 subjects per arm total of 60 subjects Responding subjects may dose for up to 104 weeks total drug exposure
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