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

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SKLB1028 150mg bid
SKLB1028 200mg bid
SKLB1028 300mg qd
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, monotherapy, SKLB1028

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • West China Hospital，Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SKLB1028 150mg bid

SKLB1028 200mg bid

SKLB1028 300mg qd

Arm Description

Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs.

Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs

Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs

Outcomes

Primary Outcome Measures

Total remission rate (ORR)
Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission（PR）

Secondary Outcome Measures

Progression-free survival time (PFS)
Total survival time (OS)
CR mitigation duration (DoR-CR)
FLT3 inhibition rate
Incidence of adverse events
Vital signs
12-lead ECG
physical examination
laboratory examination

Full Information

First Posted
May 22, 2019
Last Updated
July 12, 2019
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04015024
Brief Title
A Clinical Study of SKLB1028 Capsule in the Treatment of Recurrence/Refractory AML Patients
Official Title
Phase IIa Clinical Study of SKLB1028 Capsule in the Treatment of FLT3 Mutation Recurrence / Refractory AML Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid leukemia, monotherapy, SKLB1028

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SKLB1028 150mg bid
Arm Type
Experimental
Arm Description
Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs.
Arm Title
SKLB1028 200mg bid
Arm Type
Experimental
Arm Description
Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
Arm Title
SKLB1028 300mg qd
Arm Type
Experimental
Arm Description
Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs
Intervention Type
Drug
Intervention Name(s)
SKLB1028 150mg bid
Intervention Description
150mg oral administration twice a day
Intervention Type
Drug
Intervention Name(s)
SKLB1028 200mg bid
Intervention Description
200mg oral administration twice a day
Intervention Type
Drug
Intervention Name(s)
SKLB1028 300mg qd
Intervention Description
300mg oral administration once a day
Primary Outcome Measure Information:
Title
Total remission rate (ORR)
Description
Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission（PR）
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)
Secondary Outcome Measure Information:
Title
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
Title
Total survival time (OS)
Time Frame
30 days after last subject discontinues treatment (assessed up to approximately 24 months)
Title
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
Title
FLT3 inhibition rate
Time Frame
Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteer and sign informed consent forms Male or female Chinese patients, age ≥ 18 years old 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 Ecog score 0-3 Expected survival time greater than 3 months 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 Upper limit of normal value of serum creatinine ≤ 1.5 times The upper limit of the normal value of total bilirubin ≤ 1.5 times, except for gilbert's syndrome and leukemia involving organs. Upper limit of serum AST,ALT ≤ 3.0 times normal value, except where leukemia involves organs The subjects of childbearing age agreed to take effective contraceptives during the treatment and 6 months after the completion of the treatment. Exclusion Criteria: Diagnosed acute promyelocytic leukemia Recent symptomatic central neurosystemic leukemia There are grade 2 or more non-hematological toxicity caused by previous chemotherapy Bone marrow transplants within 100 days of the study Uncontrollable active infections (acute or chronic fungi, bacteria, viruses, or other infections) Major surgical treatment of major organs was performed in the first 4 weeks of the study Radiotherapy was performed within 4 weeks before entering the study 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 Hiv positive 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 Pregnant or lactating women There are serious diseases or complications, or diseases that the researchers determine may endanger the safety of the patient or interfere with the study Patients who are not considered to be able to enter the study Treatment is currently under way in another clinical trial or in another clinical trial within four weeks of the commencement of SKLB1028 treatment Patients who have previously received sklb1028 or other FLT3 inhibitors (midostaurin,gilteritinib, quizartinib)
Facility Information:
Facility Name
West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Liu, Dr.
Phone
86-028-85422364
Email
liuting@scu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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