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Clinical Trials in the EU / 2025-523610-83-00
Authorised Phase IV

Randomized study evaluating the impact of an innovative and cooperative pathway integrating oncogeriatric, pharmaceutical and pharmacological follow-up in elderly patients (>70 years old) presenting with cancer and treated with oral therapy _ POG

2025-523610-83-00 · tracked via the Priya Life Science EU tracker
Sponsor
Institut Gustave Roussy
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Immune System Diseases
Decision date
08/09/2026
Enrollment target
794
Sites
France

Condition studied

Elderly patients (>70 years old) presenting with cancer and treated with oral therapy in cohorts: • Breast cohort: Abemaciclib, Ribociclib, Palbociclib, Everolimus • Lung cohort: Alectinib, Brigatinib, Osimertinib • Prostate cohort: Abiraterone, Enzalutamide, Olaparib • Colon Cohort: Trifluridine+Tipiracil, Capecitabine • Kidney cohort: Axitinib, Cabozantinib, Lenvatinib • Sarcoma/ GIST cohort: Sunitinib, Regorafenib, Pazopanib

Investigational medicinal product(s)

ABEMACICLIBPAZOPANIBCAPECITABINEAXITINIBOLAPARIBTIPIRACILTRIFLURIDINEOSIMERTINIBENZALUTAMIDEPALBOCICLIBRIBOCICLIBLENVATINIBBRIGATINIBEVEROLIMUSCABOZANTINIBSUNITINIBALECTINIB HYDROCHLORIDEABIRATERONE ACETATEREGORAFENIB

Eligibility

Age group
65+ years
Sex
Female, Male

Primary endpoint

Rate of subjects who had at least one grade ≥3 non-hematologic or grade ≥4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI-CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months.

Endpoint detail

For all patients : •Number of adverse events •Averall survival • Progression-free survival •Time to discontinuation of oral anticancer treatment • Rate of subjects having had at least one hospitalization in the 24 months following inclusion.• The incremental net monetary benefit (INMB) and incremental cost-effectiveness ratio (ICER) (cost-effectiveness analysis).• Quality of life questionnaires (EORTC QLQ-C30 and EuroQol EQ5D-5L questionnaires) at baseline (M0), M1, M3, M6, M12 and M24, For patients in the interventional arm: • The average number of pharmaceutical interventions performed for the oncologist and the general practitioner • The proportion of patients with at least one potentially inappropriate drug prescription before and 3 months after pharmaceutical maintenance• The average number of medications prescribed per patient before and after the pharmaceutical interview • The complexity of the drug prescription assessed according to the MRCI score before and after

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523610-83-00 on CTIS ↗ ← All trials in the EU