Actively Recruiting
Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer
Led by University of Colorado, Denver · Updated on 2026-01-09
50
Participants Needed
2
Research Sites
185 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy. If a participant is a good fit for the study, and they enroll in the study, they will: * Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days. * Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.
CONDITIONS
Official Title
Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the entire study
- Female aged 18 years or older
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
- Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Platinum-resistant disease with progression less than 6 months after last platinum therapy
- Measurable disease according to RECIST 1.1 criteria
- Received at least one prior platinum-based chemotherapy regimen
- No more than three prior lines of systemic therapy
- Tested positive for germline or somatic BRCA mutation and/or tumor homologous recombination deficiency (HRD)
- Prior treatment with a PARP inhibitor as therapy or maintenance
- Adequate blood counts and organ function as defined in study
- Prior or concurrent malignancies allowed if not interfering with safety or study assessments
- Ability to understand and sign informed consent; legally authorized representative allowed if needed
You will not qualify if you...
- Clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal ovarian tumors
- Platinum refractory disease (progression during or within 4 weeks of platinum therapy)
- Systemic chemotherapy or radiotherapy within 3 weeks before study treatment (except palliative)
- Myelodysplastic syndrome or acute myeloid leukemia or features suggesting these
- Serious uncontrolled medical disorders or infections, including uncontrolled seizures or psychiatric disorders preventing consent
- Significant cardiac diseases including recent myocardial infarction, uncontrolled arrhythmias, unstable angina, or severe heart failure
- History of hemorrhagic or ischemic stroke within 6 months
- Cirrhotic liver disease classified as Child-Pugh B or C
- Persistent grade 2 or higher toxicities from prior cancer therapy (excluding hair loss or sensory neuropathy)
- Gastrointestinal disorders interfering with oral medication absorption
- Known untreated or symptomatic central nervous system metastases
- Known allergy to study drugs or their ingredients
- Recent surgery within 2 weeks before starting treatment without full recovery
- Inability to comply with study or follow-up procedures
- Deemed clinically unfit for trial participation by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CU Medicine Clinics
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Universtiy of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
E
Evamaria Kent Bravo, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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