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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Investigational drug
Carboplatin is an approved drug
Pegylated liposomal doxorubicin (PLD) is an approved drug
Site 0264
Aurora, Colorado, United States
RECRUITINGPart 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
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)
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
Part 2: To identify the recommended dose for Part 2 Dose Expansion
Time frame: Through Cycle 1 (21 days)
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
CONTACT
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Paclitaxel is an approved drug
Gemcitabine is an approved drug
Bevacizumab is an approved drug
Site 0104
Boston, Massachusetts, United States
RECRUITINGSite 0111
St Louis, Missouri, United States
RECRUITINGSite 0173
New York, New York, United States
RECRUITINGSite 0259
Durham, North Carolina, United States
RECRUITINGSite 0191
Providence, Rhode Island, United States
RECRUITINGSite 0196
Nashville, Tennessee, United States
COMPLETEDSite 0103
Houston, Texas, United States
RECRUITINGSite 2707
South Brisbane, Queensland, Australia
COMPLETEDSite 2708
Sunshine Coast, Queensland, Australia
COMPLETED...and 14 more locations