A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Study ID
NCT05198804
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azenosertib — DRUG
    Azenosertib
  • Niraparib — DRUG
    Niraparib

Study Details

This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer.

Key Dates

Start date
Jan 27, 2022
Status verified
Mar 2026
Primary completion
Oct 15, 2025
Completion
Jan 19, 2026

Study Design

Enrollment
117 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azenosertib and Niraparib
    Azenosertib in combination with Niraparib
  • Experimental: Azenosertib
    Azenosertib Monotherapy

Primary Outcome Measure

To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D [ Time Frame: 6 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates (Wilmot HOPE) - USORTucsonArizona85711-
Rocky Mountain Cancer CentersAuroraColorado80012-
University of ColoradoAuroraColorado80045-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Karmanos Cancer InstituteDetroitMichigan48201-
Spectrum Health SystemGrand RapidsMichigan49503-
Rutgers New Jersey Medical SchoolNewarkNew Jersey07103-
Optimum Clinical Research Group- Women's OncologyAlbuquerqueNew Mexico87109-
The Blavatnik Family - Chelsea Medical Center at Mount SinaiNew YorkNew York10011-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Women and Infants Hospital of Rhode IslandProvidenceRhode Island02905-
Texas Oncology-Fort Worth Cancer CenterFort WorthTexas76104-
MD Anderson Cancer Center, Gynecologic Oncology CenterTexas CityTexas77030-
University of VirginiaCharlottesvilleVirginia22908-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Tucson, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Arizona Oncology Associates (Wilmot HOPE) - USOR· Tucson, AZRocky Mountain Cancer Centers· Aurora, COUniversity of Colorado· Aurora, COMount Sinai Comprehensive Cancer Center· Miami Beach, FLKarmanos Cancer Institute· Detroit, MISpectrum Health System· Grand Rapids, MI

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