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Trial of ART0380 as oral and gemcitabine treatment in patients with advanced or metastatic solid tumor
THE STUDY IS BEING CONDUCTED TO ANSWER THE FOLLOWING QUESTIONS: WHAT IS THE HIGHEST DOSE OF ART0380 THAT CAN BE GIVEN TOGETHER WITH A STANDARD DOSE OF GEMCITABINE TO CANCER PATIENTS WITHOUT CAUSING SIGNIFICANT SIDE EFFECTS (ALSO KNOWN AS THE ¿RECOMMENDED DOSE¿)? HOW OFTEN CAN THE STUDY PRODUCTS BE GIVEN TO CANCER PATIENTS? WHAT ARE THE SIDE EFFECTS OF EACH OF THE STUDY PRODUCTS? WHAT ARE THE SIDE EFFECTS OF THE COMBINATION? HOW DO THE STUDY PRODUCTS AFFECT BIOMARKERS? CAN THE STUDY PRODUCTS HELP PATIENTS WITH YOUR TYPE OF CANCER? O WE WILL COMPARE THE EFFECT OF GEMCITABINE ALONE WITH THAT OF GEMCITABINE PLUS ART0380. CAN THE STUDY PRODUCTS BE SAFELY COMBINED WITH OTHER DRUGS TO TREAT YOUR TYPE OF CANCER?
Technical Summary
- PHASE I/IIA, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF ART0380, AN ATR KINASE INHIBITOR, ADMINISTERED ORALLY AS MONOTHERAPY AND IN COMBINATION TO PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS.
- Code EudraCT: 2021-003472-14
- Protocol number: ART0380C001
- Promoter: Artios Pharma Limited
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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