Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PHI 101 for the Treatment of AML
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|ClinicalTrials.gov Identifier: NCT04842370|
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 20, 2021
The purpose of this study is to find out the maximum tolerable dose and safety of PHI-101, novel FLT3 inhibitor in the treatment of relapsed or refractory AML for patients who have received standard therapy or cannot tolerate standard therapy, and/or for whom no standard therapy exists.
There will be two parts to the study, which we will call Phase Ia and Phase Ib. Phase Ia is called the dose escalation. Approximately 20 to 24 patients are planned to be enrolled into Phase Ia. Phase 1a is conducted to determine the best dose and schedule of dosing of PHI-101 to be used in Phase 1b. There will be 5 different dose levels of PHI-101 given to patients in Phase Ia.
Phase Ib is called the dose expansion. Approximately 14-34 patients (approximately 14-17 patients in each of the 2 cohorts planned) of each cohort are planned in Phase Ib based on study design. Phase Ib is also being conducted to assess anti-leukemia response, changes in transfusion requirements, and safety of PHI-101 at the dose level identified during Phase Ia.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Acute Myeloid Leukemia||Drug: PHI-101||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Phase Ia/Ib, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the FLT3 Inhibitor, PHI 101, Alone in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||June 8, 2020|
|Estimated Primary Completion Date :||May 21, 2022|
|Estimated Study Completion Date :||May 21, 2022|
|Experimental: Dose escalation and expansion of PHI-101||
PHI-101, oral, once-daily administration, consisting of 28-days per 1 cycle
- Safety assessed through adverse events to determine maximum tolerated dose [ Time Frame: From screening to the last Safety Follow up Visit(Safety Follow-up visit occurs 30 days after from EOT) ]Safety will be measured by AEs, vital signs, ECG, clinical laboratory tests, physical examination, ECOG performance.
- Tolerability assessed by dose compliance [ Time Frame: From screening to the last Safety Follow up Visit(Safety Follow-up visit occurs 30 days after from EOT) ]Tolerability will be measured by reviewing data of dose interruptions, reductions, and doses administered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842370
|Contact: Sung-Soo Yoon, MD. PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Cancer Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Sung-Soo Yoon, MD. PhD 82-2-2072-3079 email@example.com|
|Principal Investigator:||Sung-Soo Yoon, MD. PhD||Seoul National University Hospital, Seoul National University College of Medicine|