Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346632
Status:
TERMINATED
Last Update Posted:
2024-05-17
First Post:
2006-06-28
Brief Title:
An Ascending Dose Study of KW-2449 in Acute Leukemias Myelodysplastic Syndromes and Chronic Myelogenous Leukemia
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
Phase I Safety Pharmacokinetic and Pharmacodynamic Study of KW-2449 in Acute Leukemias AML Myelodysplastic Syndromes MDS and Chronic Myelogenous Leukemia CML
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to suboptimal dosing schedule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-randomized open dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML ALL MDS and CML
Detailed Description:
This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias high risk MDS and CML who are not candidates for approved therapy Over an 18-month period the investigative sites collectively will enroll up to a total of 96 subjects Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2 dosing schedules Arm A 14 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities or Arm B 28 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities The safety of a dose level in Arm A 14-day dosing regimen will be established prior to enrollment of subjects in the same dose level in Arm B 28-day dosing regimen
In April 2007 the protocol was amended to discontinue Arm B 28 consecutive days of dosing The protocol will continue as planned for Arm A 14 days of consecutive dosing
Enrollment will proceed until a maximum tolerated dose MTD has been established for each study Arm Once the MTD has been reached 12 additional subjects with 1 or more of the hematologic conditions included in this study may be enrolled at the MTD as an expanded safety cohort
In April 2007 the protocol was amended to discontinue Arm B 28 consecutive days of dosing The protocol will continue as planned for Arm A 14 days of consecutive dosing
Enrollment will proceed until a maximum tolerated dose MTD has been established for each study Arm Once the MTD has been reached 12 additional subjects with 1 or more of the hematologic conditions included in this study may be enrolled at the MTD as an expanded safety cohort
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