Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse
  • Advanced Cancer
  • Solid Tumors
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a phase 1, first-in-human, open-label, multicenter, dose escalation study. Dose escalation will follow the traditional 3+3 design. Patients will be screened for eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5 mg/day (once daily). The period for DLT ...

This is a phase 1, first-in-human, open-label, multicenter, dose escalation study. Dose escalation will follow the traditional 3+3 design. Patients will be screened for eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5 mg/day (once daily). The period for DLT assessment is 21 days from the first dose of FN-1501. Evaluation of a cohort of at least three (3) patients completing DLT assessment at any given dose level is required prior to determining the next dose level and dose regimen for the subsequent cohort. After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent patients in that cohort will not be dosed until the first patient has been evaluated for at least 48 hours to exclude unexpected acute toxicity. The continuous safety evaluation will be performed by investigators, the medical monitor, and the sponsor. A Safety Monitoring Committee (SMC) will determine dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. If an MTD is not identified due to paucity of DLTs, the RP2D will be determined based on pharmacokinetics, safety, tolerability, and preliminary efficacy. If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 21-day Cycle 2 and subsequent cycles (same as Cycle 2, all of 21 days' duration), defined as administration of 3 times per week for 2 weeks followed by one week off, at the discretion of the investigator. The primary endpoint of this study is to determine the recommended phase 2 dose (RP2D) of FN-1501 based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.

Tracking Information

NCT #
NCT03690154
Collaborators
Not Provided
Investigators
Study Director: Ai-Min Hui, MD, PhD Shanghai Fosun Pharmaceutical Development Co, Ltd.