What this study is
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.
What's being tested
- Azenosertib
Intervention · DRUG
Investigational drug
- Carboplatin
Intervention · DRUG
Carboplatin is an approved drug
- Pegylated liposomal doxorubicin
Intervention · DRUG
Pegylated liposomal doxorubicin (PLD) is an approved drug
- Paclitaxel
Intervention · DRUG
Paclitaxel is an approved drug
- Gemcitabine
Intervention · DRUG
Gemcitabine is an approved drug
- Bevacizumab
Intervention · BIOLOGICAL
Bevacizumab is an approved drug
Study details
- Official title
- A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
- Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Conditions
- Solid Tumor · Epithelial Ovarian Cancer · Fallopian Tube Cancer · Peritoneal Cancer
- Enrolling
- 172 people
- Starts
- 2020-10-26
- Est. completion
- 2028-06-30
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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:
- In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
- In the 2L setting:; Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting,; 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (24)
10 openSite 0264
Aurora, Colorado, United States
RecruitingSite 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 0103
Houston, Texas, United States
RecruitingSite 0196
Nashville, Tennessee, United States
Completed
16 sites outside the US
Site 2716
Melbourne, Victoria, Australia
RecruitingSite 2706
Melbourne, Victoria, Australia
RecruitingSite 2705
Nedlands, Western Australia, Australia
RecruitingSite 2707
South Brisbane, Queensland, Australia
CompletedSite 2708
Sunshine Coast, Queensland, Australia
CompletedSite 2709
Adelaide, South Australia, Australia
CompletedSite 1001
Banja Luka, Bosnia and Herzegovina
CompletedSite 1002
Sarajevo, Bosnia and Herzegovina
CompletedSite 1003
Tuzla, Bosnia and Herzegovina
CompletedSite 1202
Panagyurishte, Bulgaria
CompletedSite 1201
Sofia, Bulgaria
CompletedSite 1401
Tbilisi, Georgia
CompletedSite 1902
Belgrade, Serbia
CompletedSite 2901
Busan, South Korea
CompletedSite 2903
Seoul, South Korea
CompletedSite 2904
Seoul, South Korea
Completed
Study team
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Study ID ZN-c3-002
CONTACT
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.