A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
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.
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 (complet…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- 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 mus…
Interventions
- DrugAzenosertib
Investigational drug
- DrugCarboplatin
Carboplatin is an approved drug
- DrugPegylated liposomal doxorubicin
Pegylated liposomal doxorubicin (PLD) is an approved drug
- DrugPaclitaxel
Paclitaxel is an approved drug
- DrugGemcitabine
Gemcitabine is an approved drug
- BiologicalBevacizumab
Bevacizumab is an approved drug
Locations (24)
- Site 0264Aurora, Colorado
- Site 0104Boston, Massachusetts
- Site 0111St Louis, Missouri
- Site 0173New York, New York
- Site 0259Durham, North Carolina
- Site 0191Providence, Rhode Island