Health Trials

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

ConditionsSolid TumorEpithelial Ovarian CancerFallopian Tube CancerPeritoneal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Vaccine

    Bevacizumab is an approved drug

Treatment groups

172 Participants
are divided into 5 treatment groups
Group A: Part 1: Azenosertib + carboplatinExperimental treatment 2 interventions
Group B: Part 1: Azenosertib + PLDExperimental treatment 2 interventions
Group C: Part 1: Azenosertib + paclitaxelExperimental treatment 2 interventions
Group D: Part 1: Azenosertib + gemcitabineExperimental treatment 2 interventions
Group E: Part 2: Azenosertib + bevacizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine

Incidence and severity of adverse events (AEs)

Time frame
Through study completion, an average of 1 year
2

Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine

Incidence and severity of dose-limiting toxicities (DLTs)

Time frame
Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine)
3

Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab

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

Time frame
Through study completion, an average of 1 year
4

Part 2: To identify the recommended dose for Part 2 Dose Expansion

Time frame
Through Cycle 1 (21 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Lead sponsor

Source ClinicalTrials.gov
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