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A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia

NCT01756118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-02-16

No results posted yet for this study

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

Conditions

Interventions

DRUG

BEZ235

A minimum of 3 dose levels

Sponsors & Collaborators

  • Goethe University

    lead OTHER

Principal Investigators

  • Joerg Chromik, Dr. · Johann Wolfgang Goethe University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-12-31
Completion
2020-02-07

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756118 on ClinicalTrials.gov