Summary

for people ages up to 25 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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

Keywords

Malignancies Acute Lymphoblastic Leukemia (ALL) Acute Myeloid Leukemia (AML) Non-Hodgkin's Lymphoma Neuroblastoma Cancer Venetoclax pediatric relapsed or refractory Leukemia Leukemia, Myeloid, Acute Neoplasms Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid chemotherapy

Eligibility

You can join if…

Open to people ages up to 25 years

  • Participants must have relapsed or refractory cancer.
  • Participants must have adequate hepatic and kidney function.
  • Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50% and participants greater than 16 years of age must have performance status of Karnofsky greater than 50%.
  • Participants with solid tumors (with the exception of neuroblastoma) must have adequate bone marrow function in Part 1.
  • For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors must have evidence of BCL-2 expression.

You CAN'T join if...

  • Participants with primary brain tumors or disease metastatic to the brain.
  • For participants with leukemia, has overt central nervous system (CNS) disease (CNS 3 status).
  • Participants who have received any of the following within the listed time frame,prior to the first dose of study drug
  • Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
  • CAR-T infusion or other cellular therapy within 30 days
  • Anticancer therapy including blinatumomab or chemotherapy, radiation therapy,targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter
  • Steroid therapy for anti-neoplastic intent within 5 days
  • Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
  • 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:
  • Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose Determination);
  • Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort Expansion).
  • Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
  • Participants who have active, uncontrolled infections.
  • Participants with malabsorption syndrome or any other condition that precludes enteral administration.

Locations

  • Univ California, San Francisco /ID# 163460 not yet accepting patients
    San Francisco California 94143-2204 United States
  • Phoenix Childrens Hospital /ID# 202022 not yet accepting patients
    Phoenix Arizona 85016 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03236857
Phase
Phase 1
Study Type
Interventional
Last Updated