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

NCT02859948 | Unknown Phase 1

• 1 other identifier: 1028201601/PRO
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE)

  28 Days

Secondary Outcomes (11)

• Maximum serum concentration (Cmax)

  28 Days

• Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn)

  28 Days

• Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf)

  28 Days

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  28 Days

• Apparent volume of distribution at equilibrium after oral administration（Vss/F）

  28 Days

Study Arms (1)

SKLB1028

EXPERIMENTAL

SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.

Drug: SKLB1028

Interventions

SKLB1028 DRUG

SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.

SKLB1028

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Refractory to at least 1 cycle of induction chemotherapy, or
• Relapsed after at least 1 cycle of induction chemotherapy, or
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

SKLB1028

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ting Liu, Dr.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu, Dr.

CONTACT

86-028-85422364; liuting@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: August 9, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 9, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)