Phase
Condition
Malignant Ascites
Peritoneal Cancer
Digestive System Neoplasms
Treatment
ZN-c3
azenosertib
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years
High-grade serous ovarian, fallopian tube or primary peritoneal cancer
Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein statusresult determined by IHC using the Sponsor's investigational clinical trial assay
Prior therapy:
Subjects must have platinum-resistant disease
One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted,if prior mirvetuximab)
Prior bevacizumab treatment is required, if eligible per standard of care
Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, ifeligible per standard of care
Prior mirvetuximab treatment is required, if eligible per standard of care
Measurable disease per RECIST Version 1.1.
Adequate hematologic and organ function, as defined in protocol
ECOG 0-1
Exclusion
Exclusion Criteria:
Primary platinum-refractory disease
Any of the following treatment interventions within the specified time frame priorto C1D1:
Major surgery within 28 days
Hospitalization within 14 days
Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
Radiation therapy within 21 days;
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, orto discontinue consumption of food and herbal supplements that are strong ormoderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 daysprior to C1D1.
Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1inhibitor, or CHK1/2 inhibitor.
A serious illness or medical condition(s) including, but not limited to:
Clinically or radiographically unstable brain metastases or leptomeningealdisease that requires immediate treatment. Subjects with asymptomatic brainmetastases are eligible.
Myocardial impairment resulting in heart failure (NYHA Class II-IV)
Severe acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase risk associated with study participation or mayinterfere with interpretation of study results
Acute kidney injury requiring intervention or intravenous fluid in the last 14days or presence of indwelling urinary catheter or percutaneous nephrostomy.
Significant gastrointestinal abnormalities, including an inability to take oralmedication, requirement for intravenous alimentation, active peptic ulcer,chronic diarrhea or vomiting considered to be clinically significant in thejudgment of the Investigator, or prior surgical procedures affectingabsorption.
Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment andthe infection must be considered controlled/resolved (and afebrile) by theInvestigator for at least 7 days before C1D1
Any evidence of bowel obstruction as determined by air/fluid levels on computedtomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6weeks prior to C1D1.
Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
Pregnant or lactating female subject or female subject of childbearing potential whohas a positive serum pregnancy test within 14 days prior to C1D1.
History of another malignancy in the previous 2 years, unless cured by surgery aloneand continuously disease free. Exceptions include appropriately treated carcinoma insitu of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or othermalignancies with an expected curative outcome.
Subjects who are known to be immunocompromised or HIV-positive on highly activeanti-retroviral therapy.
Subjects with known active hepatitis B or hepatitis C infection.
Individuals who are judged by the Investigator to be unsuitable as study subjects.
Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
Study Design
Study Description
Connect with a study center
Site 2715 - Icon Cancer Centre - Chermside
Brisbane, Queensland 4032
AustraliaSite Not Available
Site 2707 - Mater Brisbane
South Brisbane, Queensland 4101
AustraliaSite Not Available
Site 2709 - Icon Cancer Research Adelaide
Adelaide, South Australia 5037
AustraliaSite Not Available
Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens, South Australia 5065
AustraliaSite Not Available
Site 2701 - Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Site 2717 - St John of God Hospital Subiaco
Subiaco, Western Australia 6008
AustraliaSite Not Available
Site 3616 - Centre Antoine Lacassagne
Nice, Alpes-Maritimes 06100
FranceSite Not Available
Site 3602 - Centre Oscar Lambret
Lille, Nord 59000
FranceSite Not Available
Site 3614 - Institut de Cancerologie de l'oust
Saint-Herblain, Pays de la Loire 44800
FranceSite Not Available
Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite, Rhône 69310
FranceSite Not Available
Site 3614 - Institut de Cancerologie de l'oust - Centre Rene Gauducheau
Saint-Herblain, 44805
FranceActive - Recruiting
Site 3604 - Institut Gustave Roussy
Villejuif, 94800
FranceSite Not Available
Site 2405 - Centrum Badan Klinicznych JCI
Krakow, Malopolskie 30-348
PolandSite Not Available
Site 0170-USA Mitchell Cancer Institute
Mobile, Alabama 36604
United StatesActive - Recruiting
Site 0143 - HonorHealth
Phoenix, Arizona 85016
United StatesSite Not Available
Site 0258 - UC San Diego Moores Cancer Center
La Jolla, California 92037
United StatesActive - Recruiting
Site 0124 - University of California Irvine
Orange, California 92697
United StatesSite Not Available
Site 0287 - Ridley Tree Cancer Center
Santa Barbara, California 93105
United StatesSite Not Available
Site 0135
Denver, Colorado 80218
United StatesSite Not Available
Site 0135 - Rocky Mountain Cancer Centers
Lone Tree, Colorado 80218
United StatesSite Not Available
Site 0239 - Florida Cancer Specialists - East
Daytona Beach, Florida 32117
United StatesActive - Recruiting
Site 0291 - CRC Cancer Centers of Brevard
Melbourne, Florida 32935
United StatesSite Not Available
Site 0173 - Mount Sinai Medical Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Site 0181 - Sarasota Memorial Health Care System
Sarasota, Florida 34240
United StatesSite Not Available
Site 0236 - Memorial Health
Savannah, Georgia 31404
United StatesActive - Recruiting
Site 0159 - North Shore University Health System
Evanston, Illinois 60201
United StatesSite Not Available
Site 0261 - Carle Cancer Institute
Urbana, Illinois 61801
United StatesSite Not Available
Site 0284 - Community Health Network
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Site 0313 - Beacon Health System
South Bend, Indiana 46601
United StatesSite Not Available
Site 0251 - Norton Cancer Institute
Louisville, Kentucky 40202
United StatesActive - Recruiting
Site 0146
Germantown, Maryland 20876
United StatesSite Not Available
Site 0146 - Maryland Oncology Hematology, PA
Rockville, Maryland 20876
United StatesSite Not Available
Site 0221 - Tufts Medical Center - PPDS
Boston, Massachusetts 02111
United StatesActive - Recruiting
Site 0307 - Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Site 0263 - Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
Site 0288 - Minnesota Oncology Hematology - Maplewood
Maplewood, Minnesota 55109
United StatesActive - Recruiting
Site 0310 - St. Louis Cancer Care LLP
Bridgeton, Missouri 63044
United StatesSite Not Available
Site 0157 - Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United StatesSite Not Available
Site 0226 - CoxHealth
Springfield, Missouri 65807
United StatesSite Not Available
Site 0317 - Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesSite Not Available
Site 0213 - Center of Hope
Reno, Nevada 89511
United StatesActive - Recruiting
Site 0275 - Valley Hospital
Paramus, New Jersey 07653
United StatesSite Not Available
Site 0220 - Westchester Medical Center
Hawthorne, New York 10532
United StatesSite Not Available
Site 0231 - Northwell Health Cancer Institute
Manhasset, New York 11030
United StatesSite Not Available
Site 0176 - Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Site 0259 - Duke Cancer Center
Durham, North Carolina 27710
United StatesSite Not Available
Site 0283 - Miami Valley Hospital South
Centerville, Ohio 45459
United StatesSite Not Available
Site 0147 - Trihealth Cancer Institute - Harold and Eugen
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Site 0149 - University Hospitals Case Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Site 0243 - Mark H Zangmeister Cancer Center
Columbus, Ohio 43219
United StatesActive - Recruiting
Site 0257 - Columbus NCORP
Columbus, Ohio 43215
United StatesSite Not Available
Site 0214-Ohio State University Comprehensive Cancer Center
Hilliard, Ohio 43026
United StatesSite Not Available
Site 0316 - Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401
United StatesSite Not Available
Site 0262 - Lancaster General Hospital
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Site 0232 - University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Site 0277 - Alliance Cancer Specialist, PC
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
Site 0260 - Monument Health Rapid City Hospital
Rapid City, South Dakota 57701
United StatesSite Not Available
Site 0132 - Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Site 0293 - Texas Oncology - Abilene
Abilene, Texas 79606
United StatesSite Not Available
Site 0293 - Texas Oncology - Amarillo
Amarillo, Texas 79106
United StatesSite Not Available
Site 0145- Texas Oncology - Austin
Austin, Texas 78745
United StatesSite Not Available
Site 0142 - Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United StatesSite Not Available
Site 0227
Houston, Texas 11030
United StatesSite Not Available
Site 0201 - Texas Oncology
McKinney, Texas 75071
United StatesSite Not Available
Site 0203 - Texas Oncology
Tyler, Texas 75702
United StatesSite Not Available
Site 0318 - Utah Cancer Specialists
Salt Lake City, Utah 84106
United StatesSite Not Available
Site 0295 - Virginia Oncology Associates
Chesapeake, Virginia 23320
United StatesSite Not Available
Site 0269 - Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia 24014
United StatesSite Not Available
Site 0153 - University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United StatesSite Not Available
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