Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
Status:
Completed
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
Summary
Phase Ib, open-label, dose-escalation clinical trial to evaluate the best-tolerated doses in
Acute Myeloid Leukaemia (AML) relapsed or refractory to chemotherapy.
This open-label, nonrandomized trial will comprise 2 stages. A dose escalation stage will
characterize the safety, tolerability and maximum tolerated dose (MTD), of OPB-111077.
Subsequently, an expansion stage will further evaluate the safety and antitumor activity of
OPB-111077 in AML relapsed or refractory to chemotherapy.
Enrollment to the expansion cohort will begin following determination of the MTD.
Approximately 6-12 patients will be included in the phase I part of this clinical trial.
Additional patients will be included in the expansion cohort up to a total of 15 patients.
The expansion cohort will serve to further evaluate safety simultaneously with preliminary
efficacy.
Patients will be selected and included in the study after testing the response to the drug
with the Vivia Biotech ex vivo CDx PharmaFlow PM test. PharmaFlow PM test is a companion
diagnostic (CDx) tool that provides a complete pharmacological profile for each individual,
allowing the detection of patients resistant to OPB-111077 and enriching the study in
patients that respond to the drug. The third of patients more sensitive to OPB-11077 wil be
included in the study.
Phase:
Phase 1
Details
Lead Sponsor:
Hospital Universitario 12 de Octubre
Collaborators:
Apices Soluciones S.L. Fundación para la Investigación Biomédica del Hospital 12 de Octubre Otsuka Pharmaceutical Co., Ltd. Vivia Biotech