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Recruiting Phase 1

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

NCT04516447 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2020-10-26
Last updated
2026-04-07

Condition(s) studied

Solid TumorEpithelial Ovarian CancerFallopian Tube CancerPeritoneal Cancer

Investigational drug(s) / intervention(s)

Azenosertib →Carboplatin →Pegylated liposomal doxorubicin →Paclitaxel →Gemcitabine →Bevacizumab →

Azenosertib: Investigational drug

Carboplatin: Carboplatin is an approved drug

Pegylated liposomal doxorubicin: Pegylated liposomal doxorubicin (PLD) is an approved drug

Paclitaxel: Paclitaxel is an approved drug

Gemcitabine: Gemcitabine is an approved drug

Bevacizumab: Bevacizumab is an approved drug

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA: For Part 1: * 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. For Part 2 Dose Escalation: Prior therapy: • Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy Response to prior platinum therapy: 1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy. 2. In the 2L setting: 1. Progressive Disease \>183 days after receiving the last dose of platinum chemotherapy in the 1L setting, 2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy. * Adequate hematologic, and organ function For Part 2 Dose Expansion: * Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease * Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply EXCLUSION CRITERIA: * 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. Additional protocol-defined exclusion criteria may apply

Primary outcome measure(s)

  • Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine — Through 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 gemcitabine — Through 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 bevacizumab — Through 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 Expansion — Through Cycle 1 (21 days)

Trial sites (24)

FacilityCityRegionStatus
Site 0264 Aurora Colorado Recruiting
Site 0104 Boston Massachusetts Recruiting
Site 0111 St Louis Missouri Recruiting
Site 0173 New York New York Recruiting
Site 0259 Durham North Carolina Recruiting
Site 0191 Providence Rhode Island Recruiting
Site 0196 Nashville Tennessee Completed
Site 0103 Houston Texas Recruiting
Site 2707 South Brisbane Queensland Completed
Site 2708 Sunshine Coast Queensland Completed
Site 2709 Adelaide South Australia Completed
Site 2716 Melbourne Victoria Recruiting
Site 2706 Melbourne Victoria Recruiting
Site 2705 Nedlands Western Australia Recruiting
Site 1001 Banja Luka Bosnia and Herzegovina Completed
Site 1002 Sarajevo Bosnia and Herzegovina Completed
Site 1003 Tuzla Bosnia and Herzegovina Completed
Site 1202 Panagyurishte Bulgaria Completed
Site 1201 Sofia Bulgaria Completed
Site 1401 Tbilisi Georgia Completed
Site 1902 Belgrade Serbia Completed
Site 2901 Busan South Korea Completed
Site 2903 Seoul South Korea Completed
Site 2904 Seoul South Korea Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04516447 on ClinicalTrials.gov ↗ ← All trials in the USA