Clinical Trial: NCT03236857
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | AbbVie |
| Information Provided By: | AbbVie |
| Last Update Posted: | 2023-05-22 |
Study Overview
Brief Summary
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.
Official Title
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Conditions
Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Neuroblastoma
Intervention / Treatment
- Drug: chemotherapy
- Drug: venetoclax
Other Study ID Numbers
- M13-833
- 2017-000439-14
- 2017
Start Date (Actual)
2017-11-08
Primary Completion Date (Actual)
2023-04-19
Study Completion Date (Actual)
2023-04-19
Enrollment (Actual)
143
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | AbbVie |
| Information Provided By: | AbbVie |
| Last Update Posted: | 2023-05-22 |
Study Overview
Brief Summary
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.
Official Title
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Conditions
Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Neuroblastoma
Intervention / Treatment
- Drug: chemotherapy
- Drug: venetoclax
Other Study ID Numbers
- M13-833
- 2017-000439-14
- 2017
Start Date (Actual)
2017-11-08
Primary Completion Date (Actual)
2023-04-19
Study Completion Date (Actual)
2023-04-19
Enrollment (Actual)
143
Study Type
Interventional
Phase
Phase 1