Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drug cocktail · 1 trial · 1 indication
AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90 percent (%) confidence interval (CI) of AUC(0-last) of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) (Day 20/Day 1) for each of the 5 probe drugs is reported.
To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of Cmax of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of Cmax (Day 20/Day 1) for each of the 5 probe drugs is reported.
AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of AUC(0-last) and Cmax of metabolites of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) and Cmax (Day 20/Day 1) for each of the 4 probe drug metabolites is reported (paraxanthine \[caffeine metabolite\], dextrorphan \[dextromethorphan metabolite\], OH-midazolam \[midazolam metabolite\], OH-omeprazole (omeprazole metabolite); S-warfarin does not have a metabolite).
AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.
AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.
Area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to 8, 12, and 24 hours (AUC\[0-8\], AUC\[0-12\], AUC\[0-24\], respectively).
Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.
Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.
Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.
Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.
Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.
Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.
Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.
Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.
| Arm | Type | Description |
|---|---|---|
| Single arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Drug cocktail | DRUG | Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20 |
| RO5185426 | DRUG | 960 mg orally twice daily |
Inclusion Criteria: * Adult patient \>/= 18 years of age * Malignant melanoma (Stage IV, AJCC) * Patients who are treatment-naive or have received prior systemic treatments for metastatic melanoma. Time elapsed between previous treatment for metastatic disease and first administration of study drug...
Drug cocktail is an investigational small molecule being studied for the treatment of malignant melanoma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated for its safety and pharmacokinetic profile in patients with metastatic melanoma.
Drug cocktail is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's potential in oncology, specifically for malignant melanoma. Roche is responsible for the drug's development program and clinical trial oversight.
Drug cocktail is in Phase 1 clinical development. This is the earliest stage of human testing, focused on evaluating the drug's safety, tolerability, and pharmacokinetics. The drug is investigational and has not received regulatory approval for any use. Its development is ongoing, with one completed Phase 1 trial to date.
Drug cocktail has one completed clinical trial, identified as NCT01001299. This was a Phase 1 pharmacokinetic study of RO5185426 in combination with a drug cocktail in patients with metastatic melanoma. The trial enrolled 25 participants in the United States and was not randomized or blinded.
Drug cocktail is a combination therapy that includes RO5185426 as one of its components. The clinical trial NCT01001299 evaluated the pharmacokinetics of RO5185426 when administered alongside a drug cocktail. This combination approach was studied in patients with metastatic melanoma to understand how the drugs interact.