A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Study ID
NCT04516447
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Azenosertib — DRUG
    Investigational drug
  • Carboplatin — DRUG
    Carboplatin is an approved drug
  • Pegylated liposomal doxorubicin — DRUG
    Pegylated liposomal doxorubicin (PLD) is an approved drug
  • Paclitaxel — DRUG
    Paclitaxel is an approved drug
  • Gemcitabine — DRUG
    Gemcitabine is an approved drug
  • Bevacizumab — BIOLOGICAL
    Bevacizumab is an approved drug

Study Details

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.

Key Dates

Start date
Oct 26, 2020
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
172 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Azenosertib + carboplatin
    Azenosertib in combination with carboplatin
  • Experimental: Part 1: Azenosertib + PLD
    Azenosertib in combination with pegylated liposomal doxorubicin (PLD)
  • Experimental: Part 1: Azenosertib + paclitaxel
    Azenosertib in combination with paclitaxel
  • Experimental: Part 1: Azenosertib + gemcitabine
    Azenosertib in combination with gemcitabine
  • Experimental: Part 2: Azenosertib + bevacizumab
    Azenosertib in combination with bevacizumab

Primary Outcome Measure

Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Site 0264AuroraColorado80045-
Site 0104BostonMassachusetts02215-
Site 0111St LouisMissouri53110-
Site 0173New YorkNew York10029-
Site 0259DurhamNorth Carolina27710-
Site 0191ProvidenceRhode Island02905-
Site 0196NashvilleTennessee37203-
Site 0103HoustonTexas77030-

Find similar trials in Aurora, CO

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Site 0264· Aurora, COSite 0104· Boston, MASite 0111· St Louis, MOSite 0173· New York, NYSite 0259· Durham, NCSite 0191· Providence, RI

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