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Clinical trial of Debio 0123 with carboplatin and etoposide in adult participants with relapsed or progressed small-cell lung cancer

IN THIS PHASE 1 CLINICAL TRIAL, DEBIO 0123 WILL BE ADMINISTERED IN COMBINATION WITH CARBOPLATIN AND ETOPOSIDE TO TREAT SMALL CELL LUNG CANCER (SCLC). THE DRUG BEING INVESTIGATED IN THIS STUDY, DEBIO 0123, PREVENTS CANCER CELLS FROM REPAIRING THEIR DAMAGED DNA. IT COULD THUS HELP TO DESTROY CANCER CELLS AND REDUCE THE SIZE OF THE TUMOR. THE OVERALL OBJECTIVES OF THE CLINICAL TRIAL ARE TO DETERMINE: -THE BEST DOSE OF DEBIO 0123 IN COMBINATION WITH CARBOPLATIN AND ETOPOSIDE THAT CAN BE GIVEN TO HUMAN PATIENTS (ONLY PART 1 OF THE CLINICAL TRIAL). - WHETHER DEBIO 0123 IN COMBINATION WITH CARBOPLATIN AND ETOPOSIDE IS CONSIDERED SAFE AND WITH A CONTROLLABLE AND ACCEPTABLE SAFETY PROFILE (BOTH PARTS OF THE CLINICAL TRIAL). - WHETHER THE COMBINATION OF DEBIO 0123 WITH CARBOPLATIN AND ETOPOSIDE HAS CERTAIN EFFECTS ON MPC (BOTH PARTS OF THE CLINICAL TRIAL). - HOW DEBIO 0123 IS DEGRADED IN THE BODY IN COMBINATION WITH CARBOPLATIN AND ETOPOSIDE (BOTH PARTS OF THE CLINICAL TRIAL). - WHETHER DEBIO 0123 APPEARS IN THE CENTRAL NERVOUS SYSTEM AFTER ADMINISTRATION (BOTH PARTS OF THE CLINICAL TRIAL). - IF THERE ARE GENETIC FACTORS OR TUMOR-SPECIFIC CHARACTERISTICS THAT HELP IDENTIFY WHAT INCREASES THE EFFECTIVENESS OF DEBIO 0123 IN COMBINATION WITH CARBOPLATIN AND ETOPOSIDE (BOTH PARTS OF THE CLINICAL TRIAL). - WHEN YOU RECEIVE TREATMENT WITH DEBIO 0123 IN COMBINATION WITH ETOPOSIDE AND CARBOPLATIN, YOUR WELL-BEING WILL BE ASSESSED USING A QUESTIONNAIRE (PART 2 OF THE CLINICAL TRIAL ONLY).

Cancer Center
Status
In recruitment
headquarters
Pamplona/Madrid
Early phase

Technical Summary

  • PHASE I, DOSE-ESCALATION AND ESCALATION STUDY TO EVALUATE THE SAFETY AND PRELIMINARY ANTITUMOR ACTIVITY OF DEBIO 0123 IN COMBINATION WITH CARBOPLATIN AND ETOPOSIDE IN ADULT PARTICIPANTS WITH SMALL-CELL LUNG CANCER THAT HAS RELAPSED OR PROGRESSED AFTER PRIOR CONVENTIONAL PLATINUM-DERIVATIVE THERAPY.
  • Code EudraCT: 2022-001976-32
  • Protocol number: Debio 0123-SCLC-104
  • Promoter: Debiopharm International S.A.

* 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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