A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

 Acute myeloid leukaemia / Posted 6 months ago

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.

  • Inclusion Criteria : Ages Eligible for Study: up to 25 Years (Child, Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
    • 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 or equal to 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 (except participants with TCF3-HLF ALL).
  • 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 - Inotuzumab ozogamicin or gemtuzumab ozogamicin within 30 days - Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days or 5 half-lives whichever is shorter. - CAR-T infusion or other cellular therapy within 30 days - Anticancer therapy including chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter (Exceptions: Ph+ALL participants on Tyrosine Kinase Inhibitor (TKI) at Screening may enroll and remain on TKI therapy to control disease and TCF3-HLF ALL participants are allowed to have received chemotherapy within 14 days or 5 half-lives, whichever is shorter). - Steroid therapy for anti-neoplastic intent within 5 days (with the exception of TCF3-HLF ALL participants). - 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 (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. - Participants with recent positive test for SARS-CoV-2 (COVID-19) and no follow up test with negative result cannot be enrolled. Participants with contact to persons with COVID-19 and participants with signs and symptoms for COVID-19 infection must be tested before enrolling.
  • Study end date : 25/07/2022
  • Wales-Based Study Contact : ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Contact details

Great Ormond Street Hospital for Children /ID# 169238 London, London, City Of, United Kingdom, WC1N 3JH The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938 Newcastle Upon Tyne, United Kingdom, NE1 4LP

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