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Phase II Study Testing the Tolerability and the Efficacy of Bosutinib in Chronic Phase CML Patients

NCT03205267 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2017-07-02

No results posted yet for this study

Summary

Bosutinib is a 2nd generation tyrosine kinase inhibitor that has shown promising results from first up to fourth line treatment in patients with in chronic phase of chronic myelogenous leukaemia. Most patients discontinuing the treatment with Bosutinib do so because of side effects occuring early after starting the treatment. A step in dosing scheme could improve these early toxicities. The aim of this study therefore is to demonstrate that temporary lowering of the Bosutinib dose during early treatment may help to reduce or prevent side effects while preserving efficacy.

Conditions

  • Chronic Myelogenous Leukaemia

Interventions

DRUG

Bosulif

Patients will start with dose-level 1 (300 mg once daily) Bosutinib. If patients do not experience any toxicity or only G1 toxicity, they will be dose-increased first to dose-level 2 (400 mg once daily ) and then to dose-level 3 (500 mg once daily). Dose will not be escalated above 500 mg which is the dose recommended by the summary of product information. If patients experience G2 toxicity, the study drug will be further continued at the same dose-level. In patients with G3 or G4 toxicities, therapy will be withheld until toxicity resolved to \<G2.

Sponsors & Collaborators

  • RWTH Aachen University

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • University of Jena

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • University of Bonn

    lead OTHER

Principal Investigators

  • Dominik GF Wolf, Prof. Dr. · University of Bonn Medical Faculty

  • Brümmendorf H Tim, Prof. Dr. · University of Aachen Medical Faculty

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT03205267 on ClinicalTrials.gov