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

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ClinicalTrials.gov Identifier: NCT02859948
Recruitment Status : Unknown
Verified June 2016 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: SKLB1028 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: SKLB1028
SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.
Drug: SKLB1028
SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.




Primary Outcome Measures :
  1. Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE) [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Maximum serum concentration (Cmax) [ Time Frame: 28 Days ]
  2. Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn) [ Time Frame: 28 Days ]
  3. Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf) [ Time Frame: 28 Days ]
  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 28 Days ]
  5. Apparent volume of distribution at equilibrium after oral administration(Vss/F) [ Time Frame: 28 Days ]
  6. Plasma Decay Half-Life (t1/2z) [ Time Frame: 28 Days ]
  7. Apparent Oral Clearance (CLz/F) [ Time Frame: 28 Days ]
  8. Average plasma or serum concentration(Cav) [ Time Frame: 28 Days ]
  9. changes in FLT3 mutation status in plasma [ Time Frame: 28 Days ]
  10. Rate of Complete Remission (CR) [ Time Frame: 28 Days ]
  11. Rate of partial remission (PR) [ Time Frame: 28 Days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02859948


Contacts
Contact: Ting Liu, Dr. 86-028-85422364 liuting@scu.edu.cn

Locations
China, Sichuan
West China Hospital,Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Ting Liu, Dr.    86-028-85422364    liuting@scu.edu.cn   
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
Principal Investigator: Ting Liu, Dr. West China Hospital

Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02859948     History of Changes
Other Study ID Numbers: 1028201601/PRO
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms