A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Study ID
NCT07546500
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Investigator's choice of Chemotherapy — DRUG
    The investigator will select the chemotherapy in accordance with the protocol defined requirements. The possible choices as defined by the protocol: * Paclitaxel * Gemcitabine * Pegylated liposomal doxorubicin (PLD) * Topotecan The selected chemotherapy will be administered intravenously
  • Azenosertib — DRUG
    Azenosertib 400 mg will be administered orally.

Study Details

This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.

Key Dates

Start date
Apr 17, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent schedule
  • Active Comparator: Experimental: Arm C Investigator's choice of chemotherapy at the dose defined by the protocol

Primary Outcome Measure

Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator [ Time Frame: Up to approximately 24 months from the enrollment of the last subject ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Site 0107PhoenixArizona85016-
Site 0110AntiochCalifornia94531-
Site 0115San FranciscoCalifornia94109-
Site 0101TorranceCalifornia90505-
Site 0111CamdenNew Jersey08103-
Site 0108ColumbusOhio43026-
Site 0105PortlandOregon97210-
Site 0109PhiladelphiaPennsylvania19104-
Site 0113PhiladelphiaPennsylvania19111-
Site 0114Willow GrovePennsylvania19090-
Site 0112Sioux FallsSouth Dakota57105-

Find similar trials in Phoenix, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Site 0107· Phoenix, AZSite 0110· Antioch, CASite 0115· San Francisco, CASite 0101· Torrance, CASite 0111· Camden, NJSite 0108· Columbus, OH

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