Ovarian Cancer Clinical Trial
A Study of ZN-c3 in Subjects With High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Summary
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and biomarker profile of ZN-c3 in subjects with Cyclin E driven High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at the time of informed consent.
Histologically or cytologically confirmed recurrent, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer with copy number amplification in the CCNE1 gene
Prior therapy:
Documented progressive disease ≤6 months
One to 3 prior lines or regimens are allowed
Prior bevacizumab treatment is required
Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1.
Performance Status: Eastern Cooperative Oncology Group (ECOG) score of ≤1.
Adequate hematologic and organ function
Females of childbearing potential and male subjects must agree to use an effective method of contraception prior to the first dose and for 6 months after the last dose of ZN-c3. Male subjects must agree to use an effective method of contraception prior to the first dose and for at least 3 months after the last dose of ZN-c3.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
1. Any of the following treatment interventions within the specified time frame prior to C1D1:
Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration);
Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter);
Radiation therapy within 21 days; however, if the radiation portal covered ≤5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy.
Autologous or allogeneic stem cell transplant within 3 months.
Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements, that are strong/ and moderate CYP3A4 inhibitors and inducers, or P-gp inhibitors at least 14 days prior to C1D1.
Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor.
Known hypersensitivity to any inactive ingredients present in ZN-c3.
A serious illness or medical condition(s)
Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).
Pregnant or lactating females or females of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Individuals who are judged by the Investigator to be unsuitable as study subjects.
12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).
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There are 20 Locations for this study
Lone Tree Colorado, 80218, United States
Melbourne Florida, 32935, United States
Miami Beach Florida, 33140, United States More Info
Principal Investigator
Sarasota Florida, 34240, United States More Info
Principal Investigator
Savannah Georgia, 31404, United States More Info
Principal Investigator
Rockville Maryland, 20876, United States
Springfield Missouri, 65807, United States More Info
Principal Investigator
Reno Nevada, 89511, United States More Info
Principal Investigator
Centerville Ohio, 45459, United States More Info
Principal Investigator
Columbus Ohio, 43215, United States
Lancaster Pennsylvania, 17602, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19104, United States More Info
Principal Investigator
Wynnewood Pennsylvania, 19096, United States More Info
Principal Investigator
Rapid City South Dakota, 57701, United States More Info
Principal Investigator
Amarillo Texas, 79106, United States
Dallas Texas, 75246, United States
McKinney Texas, 75071, United States
Tyler Texas, 75702, United States More Info
Principal Investigator
Roanoke Virginia, 24014, United States
Madison Wisconsin, 53792, United States More Info
Principal Investigator
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