9-ING-41 in Pediatric Patients With Refractory Malignancies.

Part of paid clinical trials in San Francisco, California.

Sponsor
Actuate Therapeutics Inc.
Study ID
NCT04239092
Phase
PHASE1
Status
Terminated

Conditions

  • Cancer Pediatric
  • Diffuse Intrinsic Pontine Glioma
  • Neuroblastoma
  • Neuroblastoma Recurrent
  • Pediatric Brain Tumor
  • Pediatric Cancer
  • Pediatric Lymphoma
  • Pediatric Meningioma
  • Refractory Cancer
  • Refractory Neoplasm
  • Refractory Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • 9-ING-41 — DRUG
    9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Cycle duration is 21 days.
  • Irinotecan — DRUG
    Irinotecan 50 mg/m2/day administered over 90 minutes IV on days 1-5 every 21 days.
  • Temozolomide — DRUG
    Temozolomide will be administered at a dose of 100 mg/m2/dose by mouth on Days 1 through 5 of a 21 day cycle.
  • Cyclophosphamide — DRUG
    Cyclophosphamide 400 mg/m2/dose administered intravenously over 30 min on Days 1 through 5 of a 21 day cycle.
  • Topotecan — DRUG
    Topotecan 1.2 mg/m2/dose administered intravenously over 30 min once on Days 1 through 5 of a 21 day cycle.

Study Details

9-ING-41 has anti-cancer clinical activity with no significant toxicity in adult patients. This Phase 1 study will study its efficacy in paediatric patients with advanced malignancies.

Key Dates

Start date
Jun 5, 2020
Status verified
Jul 2025
Primary completion
Jul 7, 2025
Completion
Jul 7, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 9-ING-41
    9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Cycle duration is 21 days.
  • Experimental: 9-ING-41 plus Irinotecan
    9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Irinotecan will be administered at a dose of 50 mg/m2/day over 90 minutes IV on days 1-5 every 21 days (cycle duration is 21 days).
  • Experimental: 9-ING-41 plus Irinotecan plus Temozolomide
    9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Irinotecan will be administered at a dose of 50 mg/m2/day over 90 minutes IV on days 1-5 every 21 days. Temozolomide will be administered at a dose of 100 mg/m2/dose by mouth on Days 1 through 5 ((cycle duration is 21 days).
  • Experimental: 9-ING-41 plus Cyclophosphamide plus Topotecan
    Cyclophosphamide 400 mg/m2/dose administered intravenously over 30 min on Days 1 through 5. Topotecan 1.2 mg/m2/dose administered intravenously over 30 min once on Days 1 through 5. 9-ING-41 intravenous infusion twice weekly (cycle duration is 21 days).

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5 [ Time Frame: 3-12 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-2549-
Children's Hospital ColoradoAuroraColorado80045-
University of ChicagoChicagoIllinois60637-
Mott Children's HospitalAnn ArborMichigan48109-
Levine Cancer CenterCharlotteNorth Carolina28204-
Duke Children's Hospital and Health Center, Duke University Medical CenterDurhamNorth Carolina27708-
Brown UniversityProvidenceRhode Island02912-
Texas Children's HospitalHoustonTexas77030-
Seattle Children's Research InstituteSeattleWashington98101-

Find similar trials in San Francisco, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
University of California, San Francisco· San Francisco, CAChildren's Hospital Colorado· Aurora, COUniversity of Chicago· Chicago, ILMott Children's Hospital· Ann Arbor, MILevine Cancer Center· Charlotte, NCDuke Children's Hospital and Health Center, Duke University Medical Center· Durham, NC

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