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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKLB1028 150mg bid | Experimental | Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs. |
|
| SKLB1028 200mg bid | Experimental | Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs |
|
| SKLB1028 300mg qd | Experimental | Repeated oral administration until there is no longer clinical benefit from therapy,or until unacceptable toxicity occurs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKLB1028 150mg bid | Drug | 150mg oral administration twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital,Sichuan University | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C576190 | SKLB1028 |
| C494814 | BID protein, human |
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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.
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| SKLB1028 200mg bid |
| Drug |
200mg oral administration twice a day |
|
| SKLB1028 300mg qd | Drug | 300mg oral administration once a day |
|
| 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) |
| Vital signs | From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) |
| 12-lead ECG | From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) |
| physical examination | From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) |
| laboratory examination | From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |