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

NCT04015024 | Unknown Phase 2

• 1 other identifier: 1028201901/PRO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; monotherapy; SKLB1028

Outcome Measures

Primary Outcomes (1)

• Total remission rate (ORR)

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

  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 Outcomes (9)

• Progression-free survival time (PFS)

  Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death

• Total survival time (OS)

  30 days after last subject discontinues treatment (assessed up to approximately 24 months)

• CR mitigation duration (DoR-CR)

  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

• FLT3 inhibition rate

  Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)

• Incidence of adverse events

  From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)

Study Arms (3)

SKLB1028 150mg bid

EXPERIMENTAL

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

Drug: SKLB1028 150mg bid

SKLB1028 200mg bid

EXPERIMENTAL

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

Drug: SKLB1028 200mg bid

SKLB1028 300mg qd

EXPERIMENTAL

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

Drug: SKLB1028 300mg qd

Interventions

SKLB1028 150mg bid DRUG

150mg oral administration twice a day

SKLB1028 150mg bid

SKLB1028 200mg bid DRUG

200mg oral administration twice a day

SKLB1028 200mg bid

SKLB1028 300mg qd DRUG

300mg oral administration once a day

SKLB1028 300mg qd

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

SKLB1028; BID protein, human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: July 10, 2019
• Study Start: July 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

CN (1)