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

View Eligibility Criteria

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).

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT05128825

Recruitment Status:

Recruiting

Sponsor:

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

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There are 24 Locations for this study

See Locations Near You

Site 0170-USA Mitchell Cancer Institute
Mobile Alabama, 36604, United States More Info
Joanie Broemmelsiek
Contact
251-445-9866
[email protected]
Jennifer Scalici
Principal Investigator
Site 0135 - Rocky Mountain Cancer Centers
Lone Tree Colorado, 80218, United States
Site 0291 - CRC Cancer Centers of Brevard
Melbourne Florida, 32935, United States
Site 0173 - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States More Info
Irina Bakura-Caso
Contact
305-674-2625
[email protected]
Brian Slomovitz
Principal Investigator
Site 0181 - Sarasota Memorial Health Care System
Sarasota Florida, 34240, United States More Info
Angele Price
Contact
941-917-3614
[email protected]
Beverly Long
Principal Investigator
Site 0236 - Memorial Health
Savannah Georgia, 31404, United States More Info
Lisa Morgan
Contact
912-350-7878
[email protected]
James Burke
Principal Investigator
Site 0146 - Maryland Oncology Hematology, PA
Rockville Maryland, 20876, United States
Site 0226 - CoxHealth
Springfield Missouri, 65807, United States More Info
Aimee Caldwell
Contact
417-269-6456
[email protected]
Jessica Gillen
Principal Investigator
Site 0213 - Center of Hope
Reno Nevada, 89511, United States More Info
Shannon Pierpoint
Contact
775-327-4673
[email protected]
Peter Lim
Principal Investigator
Site 0220 - Westchester Medical Center
Hawthorne New York, 10532, United States More Info
Allyson Pulsoni
Contact
914-493-6613
[email protected]
Tana Shah Pradhan
Principal Investigator
Site 0283 - Miami Valley Hospital South
Centerville Ohio, 45459, United States More Info
Darinda Reis
Contact
937-438-7819
[email protected]
Michael Guy
Principal Investigator
Site 0257 - Columbus NCORP
Columbus Ohio, 43215, United States
Site 0214-Ohio State University Comprehensive Cancer Center
Hilliard Ohio, 43026, United States More Info
Macy Kuhar
Contact
Floor Backes
Principal Investigator
Site 0262 - Lancaster General Hospital
Lancaster Pennsylvania, 17602, United States More Info
Susan Tollett
Contact
717-544-0511
[email protected]
Katherine Hicks-Courant
Principal Investigator
Site 0232 - University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Kristina Powell
Contact
215-220-9535
[email protected]
Fiona Simpkins
Principal Investigator
Site 0277 - Alliance Cancer Specialist, PC
Wynnewood Pennsylvania, 19096, United States More Info
Becki Banas
Contact
215-370-6701
[email protected]
Joseph Potz
Principal Investigator
Site 0260 - Monument Health Rapid City Hospital
Rapid City South Dakota, 57701, United States More Info
Angie Dunbar
Contact
605-755-2370
[email protected]
Katherine Croft
Principal Investigator
Site 0293 - Texas Oncology - Amarillo
Amarillo Texas, 79106, United States
Site 0145- Texas Oncology - Austin
Austin Texas, 78745, United States More Info
Michelle Owens
Contact
512-447-2202
[email protected]
Lynne Knowles
Principal Investigator
Site 0142 - Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Sophia Macabare
Contact
214-818-7198
[email protected]
Andrew Scott Paulson
Principal Investigator
Site 0201 - Texas Oncology
McKinney Texas, 75071, United States
Site 0203 - Texas Oncology
Tyler Texas, 75702, United States More Info
Shelly Maxfield
Contact
903-579-9840
[email protected]
Anna M Priebe
Principal Investigator
Site 0269 - Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States
Site 0153 - University of Wisconsin Clinical Science Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT05128825

Recruitment Status:

Recruiting

Sponsor:


K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

How clear is this clinincal trial information?

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