Advertisement

Topics

Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients With Myelogenous Leukemia

2014-07-24 14:11:28 | BioPortfolio

Summary

Primary objectives:

- To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen

- To evaluate the pharmacokinetic (PK) profile of SAR103168

Secondary objectives:

- To characterize the global safety profile of SAR103168

- To evaluate preliminary anti-leukemia activity

- To evaluate the inhibition of signal transducer and activators of transcription (STAT5) phosphorylation as a surrogate pharmacodynamic end point of activity

- To investigate the potential induction effect on CYP3A4 and persistence of this effect by using oral midazolam as a probe substrate in patients enrolled into the expanded cohort at the MTD

- To determine the metabolic pathways of SAR103168 and identify the chemical structures of metabolites

- To determine the potential impact of SAR103168 on the QTc-interval in patients enrolled at the MTD

Description

Patients will receive the study drug until unacceptable toxicity, clinically significant disease progression, withdrawal of consent or investigator's decision, and for a maximum of 1 year.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myelogenous Leukemia

Intervention

SAR103168

Location

Sanofi-Aventis Investigational Site Number 840002
New York
New York
United States
10021

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:28-0400

Clinical Trials [1955 Associated Clinical Trials listed on BioPortfolio]

Investigation of Clofarabine in Acute Leukemias

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphoc...

Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX l...

Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia

The purpose of this study is to test the safety of a new investigational acute myeloblastic leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced myel...

Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treati...

PubMed Articles [6610 Associated PubMed Articles listed on BioPortfolio]

Murine Retrovirally-Transduced Bone Marrow Engraftment Models of MLL-Fusion-Driven Acute Myelogenous Leukemias (AML).

MLL-rearranged leukemia represents approximately 5% to 10% of adult acute myelogenous leukemia (AML) and nearly half of all infant/pediatric acute leukemia cases. These leukemias have a poor prognosis...

Timed sequential therapy for acute myelogenous leukemia: Results of a retrospective study of 301 patients and review of the literature.

Timed sequential therapy (TST) aims to improve outcomes in acute myelogenous leukemia (AML) by harnessing drug-induced cell cycle kinetics of AML, where a second drug is timed to coincide with peak le...

Puerarin leads to K562 cell apoptosis of chronic myelogenous leukemia via induction of autophagy.

To study the effects of puerarin on the viability, apoptosis and autophagy of K562 cells of chronic myelogenous leukemia (CML), and to provide a basis for the study on antitumor mechanism of puerarin.

Mixed phenotype (T/B/myeloid) extramedullary blast crisis as an initial presentation of chronic myelogenous leukemia.

Chronic myelogenous leukemia (CML) is a myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome generated by the reciprocal translocation t(9,22)(q34;q11). The natural progressio...

Concurrent Acute Myelofibrosis and Acute Lymphoblastic Leukemia in Childhood: Case Report and Review of the Literature.

Myelofibrosis is associated with a wide variety of neoplastic and non-neoplastic bone marrow diseases, predominately myeloproliferative neoplasms and acute myeloid leukemia. The following case documen...

Medical and Biotech [MESH] Definitions

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Conditions in which the abnormalities in the peripheral blood or bone marrow represent the early manifestations of acute leukemia, but in which the changes are not of sufficient magnitude or specificity to permit a diagnosis of acute leukemia by the usual clinical criteria.

An acute myeloid leukemia in which 80% or more of the leukemic cells are of monocytic lineage including monoblasts, promonocytes, and MONOCYTES.

More From BioPortfolio on "Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients With Myelogenous Leukemia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Leukemia
Leukemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells called "blasts". Leukemia is a broad term covering a spectrum of diseases. In turn, it is part of the even broader grou...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial