Health Condition 1: A00-B99- Certain infectious and parasitic diseases Health Condition 2: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Board of Research in Nuclear Sciences (BRNS)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients requiring treatment with any of the following drugs as part of their standard care will be included: Vancomycin, Voriconazole, 5-flurouracil, nilotinib, Osimertinib and cabozantinib. 2. Eastern Cooperative Oncology Group Performance Status ranging from 0-2 3. Patients aged 18 years or older and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with known contraindications to the drugs under investigation. 2.Pregnant or breast-feeding women 3.Patients with HIV, HBV, HCV 4.Patients receiving any drug with known clinically significant drug interaction with the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with concordance between observed plasma drug concentrations and CDSS-predicted concentrations.Timepoint: Baseline (at first pharmacokinetic sampling after initiation of therapy or at steady state, as applicable) and during follow-up at drug-specific pharmacokinetic sampling time points defined in the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in predictive accuracy of the refined model, measured by reduction in prediction error metrics Relative Mean Prediction Error (RMPE%) & Relative Root Mean Squared Error (RRMSE) compared to the original generalizable model.Timepoint: Assessed after baseline pharmacokinetic sampling & re-evaluated after availability of subsequent pharmacokinetic samples during follow-up, once sufficient data are available for model refinement & validation as per protocol-defined sampling schedule.;Proportion of patients who would have benefitted from CDSS predicted dose recommendation.Timepoint: Evaluated cumulatively over the treatment period after baseline assessment, based on comparison of observed plasma drug concentrations with CDSS-predicted concentrations using all available follow-up pharmacokinetic samples collected as per protocol. | — |
Countries
India
Contacts
Public ContactDr Karunanidhan
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre
Outcome results
None listed