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Azenosertib for Ovarian, Fallopian Tube, or Peritoneal Cancer

This study is testing a new drug called azenosertib (ZN-c3) in combination with other approved cancer drugs like bevacizumab. The main goal is to see how safe azenosertib is and if it can be tolerated by people with advanced ovarian, fallopian tube, or peritoneal cancer. Researchers are also looking for early signs that the combination treatment might be effective. You may be able to join if you are a woman aged 18 or older with high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer that is FIGO Stage III/IV. You must have received 1 or 2 prior treatments, with at least one containing cisplatin or carboplatin. The study is currently focused on Part 2, which combines azenosertib with bevacizumab as a second-line maintenance therapy.

Study design
This is an open-label, multi-center Phase 1b study, meaning both you and your doctors will know which treatments you are receiving. The study plans to enroll 172 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04516447

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
~172 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:AzenosertibCarboplatinPegylated liposomal doxorubicinPaclitaxelGemcitabineBevacizumab

At a glance

Recruiting sites
10 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine
Measured over Through study completion, an average of 1 year
+3 more outcomes measured

Conditions

Solid Tumor
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmMalignant Peritoneal NeoplasmSolid Neoplasm

NCT04516447

Where you'd take part

This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site 0103

    Houston, Texasno site contact published

    Recruiting

  • Site 0104

    Boston, Massachusettsno site contact published

    Recruiting

  • Site 0111

    St Louis, Missourino site contact published

    Recruiting

  • Site 0173

    New York, New Yorkno site contact published

    Recruiting

  • Site 0191

    Providence, Rhode Islandno site contact published

    Recruiting

  • Site 0259

    Durham, North Carolinano site contact published

    Recruiting

  • Site 0264

    Aurora, Coloradono site contact published

    Recruiting

  • Site 2705

    Nedlands, Western Australia, Australiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
[email protected]
8582634333
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.
The disease must be platinum resistant (ie, the PFI must have been \< 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.
Adequate hematologic, and organ function
Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease

Exclusion

Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
Subjects with carcinosarcomas (even if there is a serous component)
A serious illness or medical condition(s)
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

What this trial measures

  • Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabineThrough study completion, an average of 1 year

    Incidence and severity of adverse events (AEs)

  • Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabineThrough Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine)

    Incidence and severity of dose-limiting toxicities (DLTs)

  • Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumabThrough study completion, an average of 1 year

    Incidence and severity of adverse events (AEs) Incidence of dose interruptions, reductions, and discontinuations due to treatment-related AEs

  • Part 2: To identify the recommended dose for Part 2 Dose ExpansionThrough Cycle 1 (21 days)