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

Part of paid clinical trials in San Francisco, California.

Sponsor
AbbVie
Study ID
NCT03236857
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • chemotherapy — DRUG
    Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan
  • venetoclax — DRUG
    Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)

Study Details

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.

Key Dates

Start date
Nov 8, 2017
Status verified
Nov 2022
Primary completion
Apr 19, 2023
Completion
Apr 19, 2023

Study Design

Enrollment
143 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax with or without chemotherapy
    Venetoclax administered orally once daily (QD) with various doses and dosing regimens with or without chemotherapy at the discretion of the investigator. Allowed chemotherapy regimens as outlined in the study protocol.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to 9 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
Univ California, San Francisco /ID# 163460San FranciscoCalifornia94143-2204-
Children's Hospital Colorado /ID# 161551AuroraColorado80045-
Children's Healthcare of Atlan /ID# 161552AtlantaGeorgia30322-
Dana-Farber Cancer Institute /ID# 163440BostonMassachusetts02215-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444New YorkNew York10065-6007-
Cincinnati Children's Hospital /ID# 161550CincinnatiOhio45229-
Children's Hospital of Philadelphia /ID# 163445PhiladelphiaPennsylvania19104-
St Jude Children's Research Hospital /ID# 163447MemphisTennessee38105-
Primary Children's /ID# 164399Salt Lake CityUtah84113-
Seattle Children's Hospital /ID# 163459SeattleWashington98105-
Medical College of Wisconsin /ID# 163461MilwaukeeWisconsin53226-3522-

Find similar trials in San Francisco, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Univ California, San Francisco· San Francisco, CAChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlan· Atlanta, GADana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center-Koch Center· New York, NYCincinnati Children's Hospital· Cincinnati, OH

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