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About
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.
Enrollment
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Inclusion criteria
Exclusion criteria
Participants with primary brain tumors or disease metastatic to the brain.
Participants who have central nervous system (CNS) disease with cranial involvement that requires radiation.
Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
Participants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.
Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
Participants who have received the following within 7 days prior to the first dose of study drug:
Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy (Exception: Chemotherapy induced side effects that are expected to return to baseline in TCF3-HLF ALL participants).
Participants who have active, uncontrolled infections.
Participants with malabsorption syndrome or any other condition that precludes enteral administration.
Primary purpose
Allocation
Interventional model
Masking
143 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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