Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02885766
Study type Interventional
Source Fusion Pharma LLC
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date July 2016
Completion date May 2020

See also
  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
Completed NCT00257647 - Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML) N/A
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 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