Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Clifutinib Besylate
Clifutinib · 5 trials · 5 indications
Overall survival was defined as the time from the date of randomization until the date of death from any cause
The CR/CRh rate was defined as the number of subjects who achieved either CR or CRh at any of the postbaseline visits divided by the number of subjects in the analysis population
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib in healthy participants.
Investigate the distribution of total radioactivity in plasma of male healthy subjects after a single oral administration of \[14C\] Clifutinib.
Quantitative analysis was conducted on the total radioactivity in the feces and urine of male health subjects after oral administration of \[14C\] Clifutinib, to obtain the data on human recovery rate and determine the main excretion pathway.
Obtain the radioactive metabolite profiles in plasma, urine and feces of male healthy subjects after oral administration of \[14C\]Clifutinib, identify the main metabolites, and determine the metabolic and elimination pathways.
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
CR + CRi +CRMRD-
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
| Arm | Type | Description |
|---|---|---|
| Clifutinib | EXPERIMENTAL | Subjects received 40 mg dose orally once a day in continuous 28-day cycles, at least 2 hours before and after food. Clifutinib treatment continued until sujects met one of the treatment discontinuation criteria. |
| Salvage Chemotherapy | ACTIVE_COMPARATOR | Subjects received chemotherapy in 28-day cycles. Subjects on Low-Dose Cytarabine (LoDAC) received 10 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10\~14 days. Subjects on azacitidine received 75 mg/m\^2 daily by SC for 7 days. Subjects on decitabine received 20 mg/m\^2 daily by IV injection for 5 days. Subjects on LoDAC or azacitidine or decitabine treatment continued until they met discontinuation criteria. Subjects on Ara-C±IDA chemotherapy received cytarabine 1\~3 g/m\^2 daily by IV for 3 days and idarubicin 10 mg/m\^2 daily by IV for 3 days. Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m\^2 daily by SC for 6 days (days 1-6), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 1\~2 g/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Subjects receiving Ara-C±IDA or FLAG-IDA received 1 cycle of therapy and were assessed for response on day 28+/-2 days. |
| Clifutinib and Itraconazole | ACTIVE_COMPARATOR | From Day 1 to Day 49, subjects will receive Itraconazole 200mg bid, and receive single dose of 40mg Clifutinib on Day 8 |
| Clifutinib and Fluconazole | ACTIVE_COMPARATOR | From Day 1 to Day 49, subjects will receive Fluconazole 400mg qd, and receive single dose of 40mg Clifutinib on Day 8 |
| Clifutinib and Efavirenz | ACTIVE_COMPARATOR | From Day 1 to Day 49, subjects will receive Efavirenz 600mg qd, and receive single dose of 40mg Clifutinib on Day 8 |
| [14C]Clifutinib | EXPERIMENTAL | On Day 1, subjects will receive a single oral dose of 40 mg/100 µCi \[14C\]Clifutinib |
| Arm 1 | EXPERIMENTAL | Queue 1:Clifutinib Besylate:30mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:30mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
| Arm 2 | EXPERIMENTAL | Queue 1:Clifutinib Besylate:40mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:40mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
| Arm 3 | EXPERIMENTAL | Queue 1:Clifutinib Besylate:60mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:60mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
| Arm 4 | EXPERIMENTAL | Clifutinib Besylate:55 mg |
| Arm 5 | EXPERIMENTAL | Clifutinib Besylate:70 mg |
| Arm 6 | EXPERIMENTAL | Clifutinib Besylate:100 mg |
| Name | Type | Description |
|---|---|---|
| Clifutinib | DRUG | tablet, oral |
| LoDAC | DRUG | subcutaneous (SC) or intravenous (IV) injection |
| Azacitidine | DRUG | SC or IV |
| Decitabine | DRUG | IV |
| Ara-C±IDA | DRUG | SC and IV |
| FLAG-IDA | DRUG | SC and IV |
| Itraconazole | DRUG | Itraconazole is taken orally approximately 30 minutes after the start of breakfast and lunch. |
| fluconazole | DRUG | Take fluconazole on an empty stomach |
| efavirenz | DRUG | Take efavirenz on an empty stomach |
| [14C]Clifutinib | DRUG | The subjects are required to take the test drug on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour. |
| Clifutinib Besylate | DRUG | The queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs |
Inclusion Criteria: * Subject is ≥ 18 years of age at the time of obtaining informed consent. * Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification; * Subject is refractory to or relapsed after first-line...
Clifutinib is an investigational small molecule being developed for acute myeloid leukemia (AML), including relapsed or refractory AML in adults and newly diagnosed AML in adults. It is also being studied in healthy subjects for food effect and mass balance trials. Clifutinib is in Phase 1 clinical development.
Clifutinib is a kinase inhibitor, as indicated by its '-tinib' suffix, which typically denotes tyrosine kinase inhibitors. The specific molecular target is not disclosed in the available data. It is being evaluated for its activity in acute myeloid leukemia.
Clifutinib is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The drug is currently in Phase 1 clinical trials for acute myeloid leukemia.
Clifutinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in acute myeloid leukemia.
Clifutinib has been studied in several Phase 1 trials, including NCT04827069 in relapsed or refractory AML, NCT05133882 in newly diagnosed AML combined with chemotherapy, NCT05454098 a food effect study in healthy subjects, and NCT07211165 a mass balance study in healthy males.
Yes, Clifutinib is also known as Clifutinib Besylate. The besylate form refers to the salt formulation of the drug used in clinical studies. Both names refer to the same investigational compound being developed for acute myeloid leukemia.