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

PHASE2UnknownINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2019

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.

Trial Locations (1)

53127

RECRUITING

University Hospital Bonn, Bonn

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

RWTH Aachen University

OTHER

collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

University of Jena

OTHER

collaborator

Heidelberg University

OTHER

collaborator

Pfizer

INDUSTRY

lead

University of Bonn

OTHER

NCT03205267 - Phase II Study Testing the Tolerability and the Efficacy of Bosutinib in Chronic Phase CML Patients | Biotech Hunter | Biotech Hunter