PF-114 Dose-finding Study in Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]
Study title
Dose-finding Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 in Adult Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]
Scientific title
A Multicenter, Open Label Cohort Phase 1 Dose Finding Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 Mesylate for Oral Administration in Adult Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML), Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
(Clinicaltrials.gov No. NCT02885766)
Type of study
Trial after therapy failure or intolerance
Current status
No longer recruiting. Interim results available.
What is the purpose of the study
In this dose-finding study, PF-114 will be given by mouth, starting with a dose of 50 mg once daily in the first patient group. In the next patient groups, the dose is gradually increased up to 400 mg/day. The dose can be increased further based on the assessment of the safety findings by the investigators and the sponsor.
Key inclusion criteria
Male or female patients 18 years of age or older with Ph+ CML in chronic phase (CP) or accelerated phase (AP) according to European LeukemiaNet guidelines (2013) can be considered for inclusion if they are intolerant to approved Bcr-Abl inhibitors or have not responded to previous treatment with at least one 2nd generation inhibitor of Bcr-Abl (dasatinib or nilotinib or bosutinib) or if they present T315I mutation in the BCR-ABL gene. In case of previous history of blast crisis phase of CML at least 6 months must have passed after the end of blast crisis phase and intake of the first dose of PF-114. To be included, patients need to have an ECOG performance status below or equal to 2 and adequate kidney, liver and heart function.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Fusion Pharma LLC
Scientific lead / contact
Veronika Shulgina MD, PhD
+7 916 815 05 44
veronika.shulgina@fusion-pharma.com
Principal investigator
1. Prof. DMSci Anna Turkina
2. Elza Lomaia MD, PhD
Study centers / principal investigators
Moscow
National Research Center for Hematology
Russia, 125 167, Moscow, Novii Zikovskii pr., 4
Principal Investigator:
Prof. DMSci Anna Turkina — Head of Myeloproliferative diseases
Clinical Study Coordinator:
Oleg Shuhov MD, PhD
shuhov@list.ru
+7 985 287 12 69
Moscow
Moscow City Centre of Hematology based on City Hospital named by S.Botkin
5, 2-nd Botkin’s lane, build. 17, entrance 3
125284 Moscow
Principal Investigator:
Prof. DMSci Olga Vinogradova — Head of Moscow City Centre of Hematology
olgavinz@mail.ru
tel. +7(495)945-97-61
St. Petersburg
Federal Almazov North-West Medical Research Centre
Russia, 197 341, St. Petersburg, Akkuratova st., 2
Principal Investigator:
Elza Lomaia MD, PhD, — lead scientist of Onco-hematology Department
lomelza@gmail.com
+7 981 936 16 67