Trials / Completed
CompletedNCT03236857
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 0 Years – 25 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Malignancies
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Non-Hodgkin's Lymphoma
- Neuroblastoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | chemotherapy | Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan |
| DRUG | venetoclax | Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet) |
Timeline
- Start date
- 2017-11-08
- Primary completion
- 2023-04-19
- Completion
- 2023-04-19
- First posted
- 2017-08-02
- Last updated
- 2023-05-22
Locations
31 sites across 8 countries: United States, Australia, Canada, France, Germany, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03236857. Inclusion in this directory is not an endorsement.