Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for O… (NCT02885766) | Clinical Trial Compass
UnknownPhase 1/2
Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
Russia65 participantsStarted 2016-07
Plain-language summary
A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety, pharmacokinetics and preliminary efficacy of PF-114 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to give written informed consent;
✓. Male or female patient ≥ 18 years old;
✓. Confirmed diagnosis of CML in chronic or accelerated phase according to European LeukemiaNet guideline as of 2013;
✓. Available information regarding resistance to the therapy with least one 2-nd generation Bcr-Abl inhibitor (dasatinib or nilotinib or bosutinib), or intolerance of approved Bcr-Abl inhibitors, or presence of T315I mutation irrespective of treatment history;
✓. In case of previous history of blast crisis phase of CML at least 6 months are required to pass after the end of blast crisis phase before the first dose of PF-114;
✓. ECOG performance status ≤ 2 (see Appendix 2);
✓. Adequate renal function defined as serum creatinine ≤ 1.5 times upper limit of normal (ULN);
✕. chemotherapy ≤ 21 days (except hydroxyurea for which washout is not required) prior to the first dose of PF-114 mesylate; оr nitrosoureas оr mitomycin С ≤ 42 days prior to the first dose of PF-114 mesylate;
✕. approved tyrosine kinase inhibitors or investigational agents ≤ 4 days prior to the first dose of PF-114;
✕. radiotherapy ≤ 28 days prior to the first dose of PF-114 ;
✕. autologous оr allogeneic stem сеll transplant \< 90 days prior to enrollment;
✕. Patient is taking medicinal products known to prolong the QT interval on the electrocardiogram, unless they are absolutely necessary in the opinion of the investigator;