A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
On this site
📄 Avastin (bevacizumab) drug profile →More K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc trials in the USA
Other trials for the same condition
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