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A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
Details
| Lead sponsor | AbbVie |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 143 |
| Start date | Wed Nov 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Apr 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Malignancies
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Non-Hodgkin's Lymphoma
- Neuroblastoma
Interventions
- chemotherapy
- venetoclax
Countries
France, Netherlands, United Kingdom, Germany, Canada, Switzerland, Australia, United States