Chronic Myeloid Leukemia Clinical Trial
Official 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
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.
PF-114 is a low molecular inhibitor of a Bcr-Abl kinase activity, which is active with
respect to native and mutated forms of this enzyme with mutations in Abl kinase domain.
Preclinical in vitro and in vivo studies have demonstrated the ability of PF-114 to inhibit
wild Bcr-Abl type and with T315I mutation, as well as other kinds of Bcr-Abl with mutations
in kinase domain, including combined mutations.
In contrast to ponatinib, PF-114 is being developed to increase the action selectivity with
respect to Bcr-Abl, which potentially should increase safety of drug application in people.
The results of performed preclinical studies confirmed improved selectivity of PF-114 action
with respect to Bcr-Abl kinases as compared to ponatinib.
Indication:
Adult patients with Ph+ CML in chronic phase (CP) or accelerated phase (AP) resistant to
previous treatment with at least one 2-nd generation inhibitor of Bcr-Abl (dasatinib,
nilotinib, bosutinib) or intolerant of approved Bcr-Abl inhibitors or with T315I mutation in
the BCR-ABL gene
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
Recruiting |
NCT03326310 -
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
|
Phase 1 | |
Recruiting |
NCT04621851 -
Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
|
||
Completed |
NCT01207440 -
Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 | |
Not yet recruiting |
NCT06409936 -
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
|
Phase 2 | |
Active, not recruiting |
NCT02917720 -
2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients
|
Phase 2 | |
Not yet recruiting |
NCT02883036 -
Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia
|
N/A | |
Withdrawn |
NCT01188889 -
RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease.
|
Phase 1/Phase 2 | |
Completed |
NCT01795716 -
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
|
Phase 1 | |
Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
Approved for marketing |
NCT00905593 -
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
|
Phase 3 | |
Terminated |
NCT00573378 -
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
|
Phase 2 | |
Terminated |
NCT00522990 -
Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
|
Phase 1/Phase 2 | |
Completed |
NCT00469014 -
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
|
Phase 2 | |
Unknown status |
NCT00598624 -
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
Completed |
NCT00257647 -
Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML)
|
N/A | |
Completed |
NCT00219739 -
STI571 ProspectIve RandomIzed Trial: SPIRIT
|
Phase 3 | |
Completed |
NCT06148493 -
Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
|
||
Completed |
NCT00375219 -
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
|
Phase 2 |