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This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.
This is a phase II, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of ABSK021 in patients with hormone refractory or relapsed cGvHD. This study consisted of Part A and Part B, all cGvHD patients in this study will receive continuous oral treatment with ABSK021 once a day (QD) in a 28-day cycle, complete the core treatment period and extended treatment period, and receive regular follow-up until the termination of treatment is determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABSK021 | Experimental | Patients will be instructed to take a specified dose of ABSK021 at the same time each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABSK021 | Drug | Patients in each phase and dose group will receive continuous treatment with oral administration once a day for 28 days/cycle until conditions for treatment termination are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity (DLT) at each dose can assess the incidence of DLT in patients during the observation period of DLT (Part A only) | Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT); | Starting from the first medication, observe for 31 days |
| Overall response rate after 6 cycles of treatment | Proportion of participants with CR or PR after 6 cycles of treatment as defined by the 2014 NIH Consensus Development Project on Criteria in cGVHD | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety assessments will be carried out during the trial. | Through study completion, an average of 2 years |
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Inclusion Criteria:
8. For patients with Part A only: antifungal drugs that are currently being used in combination with CYP3A4 potent inhibitors should have been continuously used in accordance with regulations for no less than one week before the first use of ABSK021
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China | |||
| The Second Affiliated Hospital of the Army Medical University |
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Patients will be instructed to take a specified dose of ABSK021 at the same time each day. In Cycle 1, the patient should take one dose every morning after waking up; After the 15th day of the 1st cycle, the specified dose may be taken in the morning or evening, but should be taken at the same time every day.
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| Chongqing |
| Chongqing Municipality |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
| Guangdong Provincial Peoplep's Hospital | Guangzhou | Guangdong | China |
| ZhuJiang Hospital of Southern Medical University | Zhujiang | Guangdong | China |
| Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Union Hospital, Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei | China |
| The Fir St Affiliated Hospital,Zhejiang Univer Sity School of Medicine | Hangzhou | Jiangsu | China |
| The First affiliated hospital of SuZhou University | Suzhou | Jiangsu | 215000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Hematology Hospital of Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | China |
| The First Teaching Hospital of Xinjiang Medical University | Xinjiang | Xinjiang | China |