1) Colorectal cancer 2) Gastrointestinal stromal tumors 3) Hepatocellular carcinoma 4) Renal cell carcinoma 5) Soft tissue sarcoma
Conditions
Interventions
1) PK profiles of regorafenib and its metabolites (M-2/M-5 and M-7/M-8) at week 1, 2, and 3 during the first cycle will be examined. In addition, the subsequent drug concentrations after dose adaptat
Sponsors
Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) All patients treated with regorafenib 2) All patients treated with pazopanib 3) All patients treated with axitinib 4) Patients who can give written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who are currently participating in or will be enrolled in clinical trials 2) Patients receiving molecular targeted therapy as an off-label use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To reveal the clinical benefit of therapeutic drug monitoring (TDM) of molecular targeted agents (regorafenib, pazopanib, and axitinib) in terms of prolonged duration of treatment by determining a tolerable maintenance dose in individual patients, compared with the empirical approach based only on clinical and laboratory findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To explore associations between drug exposure and clinical efficacy and safety. 2) To clarify the impact of genetic polymorphisms on the interindividual variability in plasma and urine drug concentrations. | — |
Countries
Japan
Contacts
Public ContactMasahide Fukudo
Asahikawa Medical University Department of Hospital Pharmacy and Pharmacology
Outcome results
None listed