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A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients

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ClinicalTrials.gov Identifier: NCT04015024
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary:
Patients will receive oral SKLB1028 for 28 days as a course of treatment, and then to evaluate 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 150mg bid Drug: SKLB1028 200mg bid Drug: SKLB1028 300mg qd Phase 2

Detailed Description:
It is an open,multicenter,queue extension study designed to characterize the efficacy and safety of different administration regimens of SKLB1028 capsules in patients with recurrent/refractory acute myeloid leukemia with FLT3 mutation. Divided into three dose groups,150mg BID,200mg BID,300mg QD. The main end point is total remission rate (ORR), total survival time (OS), progress-free survival time (PFS), remission duration, FLT3 suppression rate, competitive parameters, safety (incidence of adverse events).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The dose was initiated at 150 mg bid and after completion of the safety tolerance,200 mg bid was performed.300mg qd is safe and tolerant at phase 1 ,so the other participants were able to conduct the 300 mg qd test group when the safety tolerance.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIa Clinical Study of SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence / Refractory AML Patients
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: SKLB1028 150mg bid
Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs.
Drug: SKLB1028 150mg bid
150mg oral administration twice a day

Experimental: SKLB1028 200mg bid
Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
Drug: SKLB1028 200mg bid
200mg oral administration twice a day

Experimental: SKLB1028 300mg qd
Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
Drug: SKLB1028 300mg qd
300mg oral administration once a day




Primary Outcome Measures :
  1. Total remission rate (ORR) [ Time Frame: Evaluation at the end of each cycle(a cycle is 28 days) of administration and at the end of the study (assessed up to approximately 24 months) ]
    Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission(PR)


Secondary Outcome Measures :
  1. Progression-free survival time (PFS) [ Time Frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death ]
  2. Total survival time (OS) [ Time Frame: 30 days after last subject discontinues treatment (assessed up to approximately 24 months) ]
  3. CR mitigation duration (DoR-CR) [ Time Frame: Time from the date at which the patient's objective status is first noted to be a CR to the earliest date progression is documented (assessed up to approximately 24 months ]
  4. FLT3 inhibition rate [ Time Frame: Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months) ]
  5. Incidence of adverse events [ Time Frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) ]
  6. Vital signs [ Time Frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) ]
  7. 12-lead ECG [ Time Frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) ]
  8. physical examination [ Time Frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) ]
  9. laboratory examination [ Time Frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) ]


Information from the National Library of Medicine

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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:

  1. Volunteer and sign informed consent forms
  2. Male or female Chinese patients, age ≥ 18 years old
  3. In patients with primary or secondary aml diagnosed according to (who) classification of the World Health Organization, patients with FLT3 mutation were detected by leukemia cell gene, and refractory aml; after at least one cycle of induction treatment of: a) met any of the following conditions. B) recurrent aml; after at least one cycle of induction therapy
  4. Ecog score 0-3
  5. Expected survival time greater than 3 months
  6. The study drug was at least 2 weeks apart from prior cytotoxic chemotherapy (except for hydroxyl groups), or at least 5 half-lives or 4 weeks with prior non-cytotoxic chemotherapy agents, short-term
  7. Upper limit of normal value of serum creatinine ≤ 1.5 times
  8. The upper limit of the normal value of total bilirubin ≤ 1.5 times, except for gilbert's syndrome and leukemia involving organs.
  9. Upper limit of serum AST,ALT ≤ 3.0 times normal value, except where leukemia involves organs
  10. The subjects of childbearing age agreed to take effective contraceptives during the treatment and 6 months after the completion of the treatment.

Exclusion Criteria:

  1. Diagnosed acute promyelocytic leukemia
  2. Recent symptomatic central neurosystemic leukemia
  3. There are grade 2 or more non-hematological toxicity caused by previous chemotherapy
  4. Bone marrow transplants within 100 days of the study
  5. Uncontrollable active infections (acute or chronic fungi, bacteria, viruses, or other infections)
  6. Major surgical treatment of major organs was performed in the first 4 weeks of the study
  7. Radiotherapy was performed within 4 weeks before entering the study
  8. Cardiac ejection fraction below 50% or below the lower limit of normal value; patients with prolonged history of qtc (male > 450 Ms, female > 470ms); severe history of heart
  9. Hiv positive
  10. Active hepatitis B virus infection (hepatitis B virus surface antigen positive and hepatitis B dna quantity ≥ 1 × 10^3copies/ml), hepatitis C virus infection or other liver diseases
  11. Pregnant or lactating women
  12. There are serious diseases or complications, or diseases that the researchers determine may endanger the safety of the patient or interfere with the study
  13. Patients who are not considered to be able to enter the study
  14. Treatment is currently under way in another clinical trial or in another clinical trial within four weeks of the commencement of SKLB1028 treatment
  15. Patients who have previously received sklb1028 or other FLT3 inhibitors (midostaurin,gilteritinib, quizartinib)

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): NCT04015024


Locations
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China, Sichuan
West China Hospital,Sichuan University Not yet recruiting
Chengdu, Sichuan, China
Contact: Ting Liu, Dr.    86-028-85422364    liuting@scu.edu.cn   
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04015024     History of Changes
Other Study ID Numbers: 1028201901/PRO
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
Acute myeloid leukemia
monotherapy
SKLB1028
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Leukemia
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes