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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

Relapsed or Refractory Malignancies Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) Relapsed or Refractory Acute Myeloid Leukemia (AML) Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) Relapsed or Refractory Neuroblastoma Relapsed or Refractory Tumors That Expresses B Cell Lymphoma 2 (BCL-2) cancer Venetoclax pediatric Lymphoma Leukemia Leukemia, Myeloid, Acute Neoplasms Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, B-Cell Neuroblastoma

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 not yet accepting patients
    San Francisco, California, 94143, United States
  • Primary Children's not yet accepting patients
    Salt Lake City, Utah, 84113, United States
  • Seattle Children's Hospital accepting new patients
    Seattle, Washington, 98105, United States
  • Univ of Colorado Cancer Center not yet accepting patients
    Aurora, Colorado, 80045, United States
  • St. Jude Childrens Res Hosp not yet accepting patients
    Memphis, Tennessee, 38105, United States
  • Medical College of Wisconsin not yet accepting patients
    Wauwatosa, Wisconsin, 53226, United States
  • University of Cincinnati not yet accepting patients
    Cincinnati, Ohio, 45219, United States
  • Children's Healthcare of Atlan not yet accepting patients
    Atlanta, Georgia, 30322, United States
  • Children's Hosp Philadephia not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States
  • CHU Sainte-Justine accepting new patients
    Montreal, Quebec, H3T 1C5, Canada
  • Memorial Sloan-Kettering Cance not yet accepting patients
    New York, New York, 10065, United States
  • Dana-Farber Cancer Institute not yet accepting patients
    Boston, Massachusetts, 02215, United States
  • Royal Victoria Infirmary, Newc not yet accepting patients
    Newcastle Upon Tyne, NE1 4LP, United Kingdom
  • Erasmus MC - Sophia not yet accepting patients
    Rotterdam, 3015 CN, Netherlands
  • Prinses Maxima Center not yet accepting patients
    Utrecht, 3584 EA, Netherlands
  • Centre Leon Berard not yet accepting patients
    Lyon, 69373, France
  • Hopital de la Timone not yet accepting patients
    Marseille, 13385, France
  • Hopital Armand Trousseau not yet accepting patients
    Paris, 75571, France
  • Hopital Robert Debre not yet accepting patients
    Reims, 51092, France
  • CHU Toulouse not yet accepting patients
    Toulouse, 31059, France
  • Charite - Campus Virchow Klini not yet accepting patients
    Berlin, 13353, Germany
  • Univ Hosp Schleswig-Holstein not yet accepting patients
    Kiel, 24105, Germany
  • University Children's Hospital not yet accepting patients
    Zurich, 8032, Switzerland
  • Women and Childrens Hospital not yet accepting patients
    North Adelaide, South Australia, 5006, Australia
  • Royal Children's Hospital not yet accepting patients
    Melbourne, Victoria, 3052, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03236857
Phase
Phase 1
Study Type
Interventional
Last Updated
December 20, 2017
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