drugset / Trial / NCT04522284

PRECISE CURATE.AI Pilot Clinical Trial

NCT04522284

NaSingle-groupOpen-labelTreatment

Summary

In the current clinical context, drug dosing in oncology is dictated by toxicity. The optimal dosages of drugs in combinatory regimens for solid tumours are not clear, and the typical physician's decision on dose adjustment is a clinical judgement based on the degree of toxicity experienced by the patient. CURATE.AI - a small data, AI-derived technology platform - allows personalised guidance of an individual's dose modulations based only on that individual's data. Additionally, CURATE.AI is mechanism-independent, and dynamically adapts to changes experienced by the subject, providing dynamic dose optimisation throughout the duration of the subject's treatment. This study aims to demonstrate the feasibility of applying CURATE.AI in standard of care settings for treatment of solid tumours. An additional objective is to explore tumour markers in serial measurements at weekly frequency of probing, with modulated doses.

Timeline

Start
2020-08-20
Primary completion
2023-08-01
Completion
2023-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 500 mg/m2
Subject Capecitabine Small molecule 625 mg/m2
Subject Capecitabine Small molecule 1000 mg/m2
Subject Capecitabine Small molecule 1250 mg/m2
Subject Ibrutinib Small molecule 140 mg
Subject Ibrutinib Small molecule 280 mg
Subject Ibrutinib Small molecule 420 mg
Background Irinotecan Small molecule
Background Oxaliplatin Small molecule

Indications