Spots Global Cancer Trial Database for A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors
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Trial Identification
Brief Title: A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors
Official Title: 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
Study ID: NCT04029688
Study Description
Brief Summary: This is a Phase I/II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with chemotherapy or venetoclax, in pediatric and young adult participants with acute leukemias or solid tumors. This study is divided into three parts: Part 1 will begin with dose escalation of idasanutlin as a single agent in pediatric participants with relapsed or refractory solid tumors to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and to characterize dose-limiting toxicities (DLTs). Following MTD/MAD identification, three separate safety run-in cohorts in neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) will be conducted to identify the recommended Phase 2 dose (RP2D) of idasanutlin in each combination, with chemotherapy or venetoclax. Part 2 will evaluate the safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult participants in neuroblastoma, AML,and ALL cohorts at idasanutlin RP2D. Part 3 will potentially be conducted as an additional expansion phase of the idasanutlin combination cohorts in neuroblastoma, AML, or ALL for further response and safety assessment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States
Lucile Packard Children's Hospital at Stanford University; Thoracic Oncology, Palo Alto, California, United States
Arnold Palmer Hosp-Children, Orlando, Florida, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Penn State Hershey Children's Hospital, Hershey, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Huntsman Cancer Institute at The University of Utah, Salt Lake City, Utah, United States
Alberta Children'S Hospital, Calgary, Alberta, Canada
Centre Leon Berard, Lyon CEDEX 08, , France
Institut Curie, Paris, , France
CHU de Brabois, Vandoeuvre Les Nancy, , France
Gustave Roussy, Villejuif, , France
Prinses Maxima Centrum, Utrecht, , Netherlands
Hospital Sant Joan De Deu, Esplugues De Llobregas, Barcelona, Spain
Hospital Infantil Universitario Nino Jesus, Madrid, , Spain
Birmingham Children's Hospital, Birmingham, , United Kingdom
The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit, Newcastle Upon Tyne, , United Kingdom
Royal Marsden Hospital; Pediatric Unit, Surrey, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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