Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462943
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2007-04-17
Brief Title:
Open Label Study of Subcutaneous Homoharringtonine Omacetaxine Mepesuccinate in Patients With Advanced CML
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine Omacetaxine Mepesuccinate OMA in the Treatment of Patients With Chronic Myeloid Leukemia CML Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
2021-12
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:
A Phase II open-label trial of subcutaneous HHT omacetaxine mepesuccinate in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors
Detailed Description:
This will be an open label multicenter study of subcutaneous HHT omacetaxine mepesuccinate therapy of patients with chronic myeloid leukemia CML in chronic accelerated or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy Patients will be treated with induction course cycles consisting of subcutaneous SC HHT 125 mgm² twice daily for 14 consecutive days every 28 days Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted as clinically indicated according to guidelines provided in the treatment plan
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 |
|---|---|---|---|
| 2007-001286-15 | EUDRACT_NUMBER | None | None |