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

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Criteria

Inclusion Criteria:

• Written informed consent must be provided.

• Males and females age ≥ 18 years;

• Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following:

1. Refractory to at least 1 cycle of induction chemotherapy, or

2. Relapsed after at least 1 cycle of induction chemotherapy, or

3. Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;

• In the absence of rapidly progressing disease, the interval from prior treatment to time of SKLB1028 administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents;

• Serum creatinine ≤1.5 × ULN;

• Total serum bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement;

• Serum AST or ALT ≤ 3.0 × ULN unless considered due to leukemic organ involvement;

• Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study;

Exclusion Criteria:

• Histologic diagnosis of acute promyelocytic leukemia;

• Clinically active central nervous system leukemia;

• Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;

• Bone marrow transplant within 100 days prior to study;

• Active, uncontrolled infection;

• Major surgery within 4 weeks prior to study;

• Radiation therapy within 4 weeks prior to study;

• Left ventricular ejection fraction ≤1 × ULN,or﹤50%. Clinically significant ECG QTc prolongation (Male: >450ms, Female: >470ms).Significant cardiac disease.

• Human immunodeficiency virus positivity;

• Active hepatitis B or C or other active liver disease;

• Women who are pregnant, lactating;

• Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.