Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Dabrafenib twice a day is an investigational small molecule being studied for the treatment of cancer. It is being evaluated in patients with BRAF V600 mutation positive tumors. The drug is currently in Phase 1 clinical development.
Dabrafenib twice a day is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this drug for the oncology therapeutic area.
Dabrafenib twice a day is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial for this drug has been completed.
Dabrafenib twice a day has been studied in one completed Phase 1 clinical trial, identified as NCT01954043. This trial examined the effects of rabeprazole and rifampin on dabrafenib in subjects with BRAF V600 mutation positive tumors.
Dabrafenib twice a day targets the BRAF V600 mutation, which is present in certain tumors. By acting on this molecular target, the drug is being studied for its potential effect in treating cancer. The exact mechanism is under investigation in clinical trials.