Actively Recruiting
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
42
Participants Needed
27
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.
CONDITIONS
Official Title
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women age 18 years or older
- Histologically confirmed recurrent platinum-resistant epithelial ovarian carcinoma
- High-grade serous histology required for dose expansion cohort
- Patients must have received 1-3 prior systemic therapies
- ECOG performance status of 0, 1, or 2 (Karnofsky score 60%)
- Hemoglobin 10 g/dL within 28 days before treatment
- Absolute neutrophil count 1,500/mcL within 28 days before treatment
- Platelets 100,000/mcL within 28 days before treatment
- Total bilirubin = 1.5 times the institutional upper limit of normal within 28 days before treatment
- AST and ALT = 3 times institutional upper limit of normal (or = 5 times if liver metastases present) within 28 days before treatment
- Creatinine clearance 51 mL/min within 28 days before treatment
- Glomerular filtration rate 60 mL/min/1.73 m2 within 28 days before treatment
- HIV-positive patients on effective therapy with undetectable viral load within 6 months
- Patients with controlled hepatitis B or treated hepatitis C infection
- Stable treated brain metastases for at least 4 weeks off corticosteroids
- Cardiac function classified as New York Heart Association class 2B or better
- Postmenopausal or non-childbearing status confirmed with negative pregnancy test
- Use of effective contraception for women of childbearing potential and partners
- Disease accessible for biopsy for dose expansion cohort
- Informed consent for optional genetic and biomarker research
- No prior CDK 4/6 inhibitors; prior PARP inhibitor allowed only in front-line treatment
- Recovery from prior chemotherapy, radiotherapy, or other agents with appropriate washout periods
- Ability to understand and sign informed consent (or legally authorized representative)
You will not qualify if you...
- Receiving any other investigational agents
- Allergic or hypersensitive to abemaciclib, olaparib, or their ingredients
- Concurrent use of strong or moderate CYP3A inhibitors without proper washout
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding women
- Other malignancies unless treated and disease-free for at least 5 years (with some exceptions)
- Uncontrolled or reversible cardiac conditions or abnormal ECG findings
- History or signs of myelodysplastic syndrome or acute myeloid leukemia
- Serious uncontrolled medical disorders or infections
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Major surgery within 2 weeks before starting treatment
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Active systemic fungal infection
- Suspected or history of interstitial lung disease or pneumonitis
- Active thromboembolism within the last 6 months or ongoing signs despite treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Active, Not Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Active, Not Recruiting
7
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Active, Not Recruiting
8
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Active, Not Recruiting
9
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Active, Not Recruiting
10
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Active, Not Recruiting
11
Northwestern University
Chicago, Illinois, United States, 60611
Active, Not Recruiting
12
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
13
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Suspended
14
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Suspended
15
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Suspended
16
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Suspended
17
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
18
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Suspended
19
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Suspended
20
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Suspended
21
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Terminated
22
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
23
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
24
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
25
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
26
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
27
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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