Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510939
Status:
UNKNOWN
Last Update Posted:
2009-08-14
First Post:
2007-08-02
Brief Title:
Study to Assess the Safety Tolerability and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Acute Myeloid Leukemia
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Phase II Open-Label Multi-centre 2-part Study to Assess the Safety Tolerability and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Newly Diagnosed Acute Myeloid Leukemia AML Unfit for Conventional Chemotherapy 18 Years or in Patients With Acute Myeloid Leukemia in First Relapse 60 Years
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
RECRUITING
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:
HEMOS AML 0106
Brief Summary:
This is one of the first studies of combination of Zarnestra plus Velcade in man A primary objective of the study is therefore to assess the safety and tolerability of multiple doses of Zarnestra plus Velcade in patients with AML
New treatments for patients that are untreatable with intensive chemotherapy aged de novo AML patients or post-relapse AML are urgently required since at present many of the drugs used for second line therapy are the same as those used for first induction and response rates are much lower
The following evidence suggests that Velcade plus Zarnestra can be an attractive therapeutic combination for AML patients
Affymetrix gene profiling data showed expression of NFkB1 in all of 5 myeloid cell lines cell lines tested and 35 of over 250 patient samples data generated in collaboration with Sergio Ferrari and Pier Paolo Piccaluga unpublished results our Institute and University of ModenaItaly
Preclinical evidence showed that AML cells in suspension culture were prevented to develop de novo drug resistance and mediated drug resistance
In Part B additional patients with AML will be treated to further characterize the tolerabilitybiological effects and clinical efficacy of the combination Velcade plus Zarnestra Patients on treatment for AML will undergo regular bone marrow aspirates and biopsies to assess responses to treatment This will facilitate frequent assessment of biological endpoints reduction in expression and phosphorylation of IKKb kinase and downstream markers of signalling along with apoptosis survival proliferation and cellular size and ploidy will be made in an attempt to confirm that the desired biological activity has been achieved at the maximum tolerated dose
New treatments for patients that are untreatable with intensive chemotherapy aged de novo AML patients or post-relapse AML are urgently required since at present many of the drugs used for second line therapy are the same as those used for first induction and response rates are much lower
The following evidence suggests that Velcade plus Zarnestra can be an attractive therapeutic combination for AML patients
Affymetrix gene profiling data showed expression of NFkB1 in all of 5 myeloid cell lines cell lines tested and 35 of over 250 patient samples data generated in collaboration with Sergio Ferrari and Pier Paolo Piccaluga unpublished results our Institute and University of ModenaItaly
Preclinical evidence showed that AML cells in suspension culture were prevented to develop de novo drug resistance and mediated drug resistance
In Part B additional patients with AML will be treated to further characterize the tolerabilitybiological effects and clinical efficacy of the combination Velcade plus Zarnestra Patients on treatment for AML will undergo regular bone marrow aspirates and biopsies to assess responses to treatment This will facilitate frequent assessment of biological endpoints reduction in expression and phosphorylation of IKKb kinase and downstream markers of signalling along with apoptosis survival proliferation and cellular size and ploidy will be made in an attempt to confirm that the desired biological activity has been achieved at the maximum tolerated dose
Detailed Description:
None
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 |
|---|---|---|---|
| EudraCT 2007-000273-35 | None | None | None |