Status:
COMPLETED
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Roche-Genentech
Conditions:
Malignancies
Acute Lymphoblastic Leukemia (ALL)
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE1
Brief 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), ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2023
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03236857
Start Date
November 8 2017
End Date
April 19 2023
Last Update
May 22 2023
Active Locations (31)
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1
Univ California, San Francisco /ID# 163460
San Francisco, California, United States, 94143-2204
2
Children's Hospital Colorado /ID# 161551
Aurora, Colorado, United States, 80045
3
Children's Healthcare of Atlan /ID# 161552
Atlanta, Georgia, United States, 30322
4
Dana-Farber Cancer Institute /ID# 163440
Boston, Massachusetts, United States, 02215