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Dabrafenib twice a day · 1 trial · 1 indication
Blood samples will be collected to assess PK parameters including: maximum observed concentration (Cmax)
Blood samples will be collected to assess PK parameters including: time to Cmax (tmax)
Blood samples will be collected to assess PK parameters including: area under the concentration-time curve over the dosing interval (AUC\[0-tau\])
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Subjects will administer Dabrafenib from Day 1 to Day 15, Dabrafenib and Rabeprazole from Day 16 to Day 19, Dabrafenib and Rifampin from Day 20 to Day 29. The serial PK samples will be collected for 12 hours following dosing on Day 15 (Dabrafenib alone), Day 19 (Dabrafenib and Rabeprazole), and Day 29 (Dabrafenib and Rifampin). |
| Name | Type | Description |
|---|---|---|
| Dabrafenib 150 mg twice a day (BID) | DRUG | Dabrafenib dosed at 150mg twice a day from Day 1 to the morning of Day 29 |
| Rabeprazole 40 mg once daily (OD) | DRUG | Rabeprazole dosed at 40mg each morning on Days 16 to 19 |
| Rifampin 600 mg OD | DRUG | Rifampin dosed at 600mg each morning on Days 20 to 29 |
Inclusion Criteria: * Male or female at least 18 years of age at the time of signing the informed consent form. * Provided signed written informed consent. * Capable of compliance with the requirements and restrictions listed in the consent form. * Body weight \>=45 kilogram (kg) and a body mass in...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Dabrafenib twice a day is a dosing regimen of dabrafenib given at 150 mg twice daily (BID) to patients with cancer. It is a small molecule drug developed by GSK plc (ticker: GSK). The regimen has been studied in a Phase 1 pharmacokinetics trial in patients with BRAF V600 mutation positive tumors.
Dabrafenib twice a day is used in cancer, specifically in patients with BRAF V600 mutation positive tumors. The studied population was biomarker selected, meaning treatment is directed at tumors carrying the BRAF V600 mutation. The Phase 1 trial enrolled 23 adult patients aged 18 years and older across the United States, Australia, and the United Kingdom.
Dabrafenib twice a day targets BRAF, a kinase in the MAPK signaling pathway. It acts as an inhibitor of BRAF, and the clinical program is restricted to BRAF V600 mutation positive tumors, so the target mutation is used to select patients. The ChEMBL identifier for dabrafenib is CHEMBL2028663.
Dabrafenib twice a day is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor associated with the clinical development of this dabrafenib dosing regimen. The asset is a small molecule in the oncology therapeutic area.
Dabrafenib twice a day is in Phase 1 development. The single registered trial, NCT01954043, is a completed Phase 1 pharmacokinetics study, and no active trials of this regimen are listed. It is an investigational dosing regimen studied in a biomarker selected cancer population.
Dabrafenib twice a day has been studied in one clinical trial, NCT01954043, titled A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors. It was a completed Phase 1, uncontrolled study that enrolled 23 patients in the United States, Australia, and the United Kingdom.