Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Encorafenib
Encorafenib formulation · 1 trial · 1 indication
AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Cmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data.
AUClast for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated using Linear/Log trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| Four Period Treatment Sequence: PPI Effect | EXPERIMENTAL | Participants will receive a single encorafenib dose formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the formulation after administration of 20 mg rabeprazole every evening for 5 days. |
| Four Period Treatment Sequence: PPI Effect Second Formulation | EXPERIMENTAL | Participants will receive a single encorafenib dose of the second formulation, a single encorafenib dose of the second formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the second formulation after administration of 20 mg rabeprazole every evening for 5 days. |
| Name | Type | Description |
|---|---|---|
| Encorafenib capsule formulation (CAP) | DRUG | A single encorafenib dose of the CAP formulation |
| Encorafenib first formulation | DRUG | first formulation |
| Encorafenib second formulation | DRUG | second formulation |
| Rabeprazole tablet | DRUG | Proton-pump inhibitor |
Inclusion Criteria: * Participants must be male or female of non-childbearing potential of 18 years of age or older, inclusive, at the time of signing the informed consent document. * Male and female participants who are overtly healthy as determined by medical evaluation including medical history,...
Encorafenib is an investigational small molecule being studied for the treatment of cancers including metastatic colorectal cancer, melanoma, and solid tumors harboring a BRAF V600 mutation. It is in Phase 3 clinical development for these oncology indications.
Encorafenib is a kinase inhibitor, belonging to the -nib class of drugs. It targets and inhibits BRAF kinases, which are involved in cell growth and proliferation. By blocking these kinases, Encorafenib aims to slow or stop the growth of cancer cells that harbor BRAF mutations.
Encorafenib is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
Encorafenib is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in ongoing and completed clinical trials.
Encorafenib has been studied in several clinical trials, including NCT01909453, a Phase 3 trial in BRAF mutant melanoma; NCT02159066, a Phase 2 trial in advanced BRAF melanoma; NCT02928224, a Phase 3 trial in BRAF V600E-mutant metastatic colorectal cancer; and NCT04657991, an active Phase 3 trial in advanced or metastatic melanoma.
Yes, Encorafenib is also known as LGX818. Clinical trial titles and protocols often refer to the drug by this alternative name, such as in studies combining LGX818 with other agents for the treatment of BRAF-mutant cancers.