Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

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

SKLB1028

Ting Liu, Dr.

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.

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.

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

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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Dose-escalation stage: Patients will receive SKLB1028 capsules orally once daily (QD) in continuous 28-day cycles, in three doses beginning at 200 mg and rising to 400 mg.

Cohort-expansion stage: Patients will receive SKLB1028 capsules orally once daily (QD) in continuous 28-day cycles at selected dose as per the results of dose-escalation stage.

SKLB1028 capsules, oral, once daily in continuous 28-day cycles

Xuefang Xia

Suxia Luo, Master

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors.

This study is divided into two stages. The first stage is the dose-escalation stage to evaluate the safety, tolerance and pharmacokinetics of SKLB1028 in patients with advanced solid tumors. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD). Patients with advanced solid tumors will receive SKLB1028 orally once daily (QD) in continuous 28-day cycles, starting at a dose of 200 mg and rising to 400 mg. The second stage is cohort-expansion study. The safe tolerated dose group will be selected for case expansion. At this stage, patients with advanced solid tumors with better response on SKLB1028 are mainly enrolled.

A Study of SKLB1028 in Patients With Advanced Solid Tumor

An Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SKLB1028 in Patients With Advanced Solid Tumors

To identify the dose-limited toxicity (DLT).

To identify the maximum tolerated dose (MTD）

TEAE is defined as an adverse event that occurs during treatment

Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of SKLB1028

ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

PFS is defined as the time from the date of first dose until the date of first documented PD as per RECIST 1.1 or death from any cause, whichever occurs first

DCR is defined as the proportion of patients who have a response of CR/PR or stable disease (SD) as per RECIST 1.1

DoR is defined as the time from the first assessment of CR or PR until the date of first occurrence of progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia	NCT02859948	Acute Myeloid L...	SKLB1028	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study of SKLB1028 in Patients With Advanced Solid Tumor	NCT05072522	Advanced Solid ...	SKLB1028	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study of SKLB1028 in Patients With Advanced Solid Tumor	NCT05072522	Advanced Solid ...	SKLB1028	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study of SKLB1028 in Patients With Advanced Solid Tumor	NCT05072522	Advanced Solid ...	SKLB1028	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Spots Global Cancer Trial Database for sklb1028

Every month we try and update this database with for sklb1028 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sklb1028

Every month we try and update this database with for sklb1028 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sklb1028 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.