Phase I/II clinical trial - Pédiatrie Tumeurs solides

GO40871
Pédiatrie Tumeurs solides
Ouvert depuis le: 10.17.2021
Site: Paris
Public cible
Enfant
A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM;STUDY EVALUATING THE SAFETY, TOLERABILITY,;PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF;IDASANUTLIN IN COMBINATION WITH EITHER;CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF;PEDIATRIC AND YOUNG ADULT PATIENTS WITH;RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID;TUMORS
Description de l'essai

The study is divided into three parts:;À Study Part 1:;- Dose escalation to assess safety, tolerability, and pharmacokinetics of idasanutlin as a single-agent treatment in the pediatric population with relapsed or refractory solid-tumor cancer; to identify the single-agent MTD/MAD; and to characterize DLTs. Patients in dose escalation after one cycle will either continue single-agent idasanutlin or start early combination of idasanutlin with chemotherapy (for precise rules, see protocol).;- Following single-agent MTD/MAD identification, three separate safety run-in cohorts in neuroblastoma, AML, and ALL will be conducted with newly enrolled pediatric patients to identify the RP2D(s) of idasanutlin in each combination, with chemotherapy or venetoclax.;À Study Part 2: Evaluation of safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult patients in neuroblastoma, AML, and ALL cohorts at idasanutlin RP2D.;À Study Part 3: Potential expansion of idasanutlin combination cohorts in neuroblastoma, AML, or ALL meeting the pre-defined efficacy criteria for expansion, also taking into account practical considerations (e.g., enrollment feasibility), nonclinical findings, biomarker analysis, safety profiles, and any other relevant information.