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A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
NCT04516447 · K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
In plain English
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Official title
A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
About this study
This is a Phase 1b open-label, multicenter study evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (also known as ZN-c3) in combination with chemotherapy or bevacizumab. This study consists of 2 parts:
Part 1 (completed and no longer recruiting): Azenosertib in combination with chemotherapy Azenosertib was assessed in combination with chemotherapy in subjects with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer.
Part 2: Azenosertib in combination with bevacizumab
* Dose Escalation (completed and no longer recruiting): Azenosertib was assessed in combination with bevacizumab as first-line (1L) or second-line (2L) maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy to determine a recommended dose for expansion.
* Dose Expansion: Azenosertib will be assessed in combination with bevacizumab as 2L maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy.
Eligibility criteria
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
Study design
Enrollment target: 172 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-10-26
Estimated completion: 2028-06-30
Last updated: 2026-04-07
Interventions
Drug: AzenosertibDrug: CarboplatinDrug: Pegylated liposomal doxorubicinDrug: PaclitaxelDrug: GemcitabineBiological: Bevacizumab
Primary outcomes
- • 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)
- • 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))
- • Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab (Through study completion, an average of 1 year)
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · industry
Contacts & investigators
ContactK-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals · contact · medicalaffairs@zentalis.com · 8582634333
All locations (24)
Site 0264Recruiting
Aurora, Colorado, United States
Site 0104Recruiting
Boston, Massachusetts, United States
Site 0111Recruiting
St Louis, Missouri, United States
Site 0173Recruiting
New York, New York, United States
Site 0259Recruiting
Durham, North Carolina, United States
Site 0191Recruiting
Providence, Rhode Island, United States
Site 0196Completed
Nashville, Tennessee, United States
Site 0103Recruiting
Houston, Texas, United States
Site 2707Completed
South Brisbane, Queensland, Australia
Site 2708Completed
Sunshine Coast, Queensland, Australia
Site 2709Completed
Adelaide, South Australia, Australia
Site 2716Recruiting
Melbourne, Victoria, Australia
Site 2706Recruiting
Melbourne, Victoria, Australia
Site 2705Recruiting
Nedlands, Western Australia, Australia
Site 1001Completed
Banja Luka, Bosnia and Herzegovina
Site 1002Completed
Sarajevo, Bosnia and Herzegovina
Site 1003Completed
Tuzla, Bosnia and Herzegovina
Site 1202Completed
Panagyurishte, Bulgaria
Site 1201Completed
Sofia, Bulgaria
Site 1401Completed
Tbilisi, Georgia
Site 1902Completed
Belgrade, Serbia
Site 2901Completed
Busan, South Korea
Site 2903Completed
Seoul, South Korea
Site 2904Completed
Seoul, South Korea