Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438178
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2007-02-21
Brief Title:
Safety and Efficacy of Obatoclax Mesylate GX15-070MS for the Treatment of Hematological Malignancies
Sponsor:
Gemin X
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Phase I Study of Obatoclax Mesylate GX15-070MS in Patients With Acute Myeloid Leukemia AML Myelodysplastic Syndrome MDS Chronic Myeloid Leukemia CMLin Myeloid Blast Phase Myelofibrosis Previously-Treated Chronic Lymphocytic Leukemia CLL or Aplastic Anemia
Status:
COMPLETED
Status Verified Date:
2014-05
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:
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins thereby reinstating the natural process of cell death that is often inhibited in cancer cells
Detailed Description:
This is a multi-center open-label Phase I study of obatoclax administered every 2-week or weekly cycles or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid Leukemia AML Myelodysplastic Syndrome MDS Chronic Myeloid Leukemia CMLin Myeloid Blast Phase Myelofibrosis Previously-Treated Chronic Lymphocytic Leukemia CLL or Aplastic Anemia Due to the PKPD sampling schedule Cycle 1 will require overnight hospitalization For the following cycles treatment may be administered on an outpatient basis but is at the discretion of the investigator No investigational or commercial agents or therapies other than those described within the protocol may be administered with the intent to treat the patients malignancy Supportive care measures including those directed at controlling symptoms resulting from hematological malignancies are allowed
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