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Official title A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
ClinicalTrials.gov ID: NCT04516447
What this study is testing
What is Azenosertib?
Azenosertib is an investigational medicine, being studied as a potential treatment for solid tumor.
Also referred to as ZN-c3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- For Part 1:
- Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
- people must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have...
- The disease must be platinum resistant (ie, the PFI must have been \< 6 months). Platinum refractory disease (ie, PD during first-line platinum-based...
- people must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy Response to prior...
You likely can't join if
- Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
- people with carcinosarcomas (even if there is a serous component)
- A serious illness or medical condition(s)
- people with active (uncontrolled, metastatic) second malignancies or requiring therapy. Additional protocol-defined exclusion criteria may apply
See the full eligibility criteria
- For Part 1:
- Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
- people 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:
- people 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:
- people must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease
- people must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined may apply
- Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
- people with carcinosarcomas (even if there is a serous component)
- A serious illness or medical condition(s)
- people with active (uncontrolled, metastatic) second malignancies or requiring therapy. Additional protocol-defined exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- South Brisbane, Queensland, Australia
- Sunshine Coast, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Banja Luka, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- Tuzla, Bosnia and Herzegovina
- Panagyurishte, Bulgaria
- Sofia, Bulgaria
- Tbilisi, Georgia
- Belgrade, Serbia
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; New York, New York, United States; Durham, North Carolina, United States; Providence, Rhode Island, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.