A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
Start Date
10/26/2020
Completion Date
6/30/2028
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.
Detailed Description
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
Age Range: 18 years to No maximum
Interventions
Azenosertib
Carboplatin
Pegylated liposomal doxorubicin
Paclitaxel
Gemcitabine
Bevacizumab
Conditions
Locations
Site 0264
Aurora, Colorado 80045
United States
Site 0104
Boston, Massachusetts 02215
United States
Site 0111
St Louis, Missouri 53110
United States
Site 0173
New York, New York 10029
United States
Site 0259
Durham, North Carolina 27710
United States
Site 0191
Providence, Rhode Island 02905
United States
Site 0196
Nashville, Tennessee 37203
United States
Site 0103
Houston, Texas 77030
United States
Site 2707
South Brisbane, Queensland 4101
Australia
Site 2708
Sunshine Coast, Queensland 4556
Australia
Site 2709
Adelaide, South Australia 5000
Australia
Site 2716
Melbourne, Victoria 3121
Australia
Site 2706
Melbourne, Victoria 3144
Australia
Site 2705
Nedlands, Western Australia 6009
Australia
Site 1001
Banja Luka, 78000
Bosnia and Herzegovina
Site 1002
Sarajevo, 71000
Bosnia and Herzegovina
Site 1003
Tuzla, 75000
Bosnia and Herzegovina
Site 1202
Panagyurishte, 4500
Bulgaria
Site 1201
Sofia, 1632
Bulgaria
Site 1401
Tbilisi, 0112
Georgia
Site 1902
Belgrade, 11080
Serbia
Site 2901
Busan,
South Korea
Site 2903
Seoul, 03080
South Korea
Site 2904
Seoul, 05505
South Korea