Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01756118
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2012-12-19
Brief Title:
A Phase I Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
Sponsor:
Goethe University
Organization:
Goethe University
Study Overview
Official Title:
A Phase I Dose-finding Study of the Oral Dual Phosphatidylinositol 3PI3-Kinase Mammilian Target of Rapamycin mTOR Inhibitor BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Primary objectives
To establish the maximum tolerated dose MTD and the recommended Phase 2 dose RP2D of BEZ235 when administered twice daily BID as a single agent in patients with relapsed or refractory acute leukemia
To determine the dose-limiting toxicity DLT
Secondary objectives
Assess the safety and tolerability of daily oral administration of BEZ235 with a BID schedule
To describe preliminary anti-leukemic activity of BEZ235 in patients with acute leukemia
To correlate changes in pharmacodynamic biomarkers with basic pharmacokinetic data
Exploratory objectives
To assess pre-treatment phosphatidylinositol 3-kinase PI3K pathway-related genes in blast cells and all other malignant cells derived from blood or bone marrow
To assess the pharmacodynamic changes in components of the PI3K-protein kinase B AKT-mTOR pathway in bone marrow following treatment as potential predictive biomarkers of pharmacodynamic PD activity of BEZ235 in association with clinical responses
To identify potential resistance mechanisms and biomarkers that may correlate with efficacy and response from blood and bone marrow samples pre-and post-treatment in case of resistance
To establish the maximum tolerated dose MTD and the recommended Phase 2 dose RP2D of BEZ235 when administered twice daily BID as a single agent in patients with relapsed or refractory acute leukemia
To determine the dose-limiting toxicity DLT
Secondary objectives
Assess the safety and tolerability of daily oral administration of BEZ235 with a BID schedule
To describe preliminary anti-leukemic activity of BEZ235 in patients with acute leukemia
To correlate changes in pharmacodynamic biomarkers with basic pharmacokinetic data
Exploratory objectives
To assess pre-treatment phosphatidylinositol 3-kinase PI3K pathway-related genes in blast cells and all other malignant cells derived from blood or bone marrow
To assess the pharmacodynamic changes in components of the PI3K-protein kinase B AKT-mTOR pathway in bone marrow following treatment as potential predictive biomarkers of pharmacodynamic PD activity of BEZ235 in association with clinical responses
To identify potential resistance mechanisms and biomarkers that may correlate with efficacy and response from blood and bone marrow samples pre-and post-treatment in case of resistance
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 |
|---|---|---|---|
| 2011-005050-61 | EUDRACT_NUMBER | None | None |