NCT02859948

A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKLB1028 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.

Detailed description

It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered SKLB1028 as a single agent given daily for 28 days. Cohorts of 3 patients receive SKLB1028 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined. Patients not experiencing DLT or significant disease progression could continue receiving SKLB1028 up to 1 year.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	SKLB1028	SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-08-09
• Last updated: 2016-08-09

Locations

1 site across 1 country: China