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Cirtuvivint and Olaparib for Platinum-Resistant Ovarian Cancer

This study is testing a combination of two medications, Cirtuvivint and Olaparib, for women with ovarian, primary peritoneal, or fallopian tube cancer that has not responded to platinum-based chemotherapy. You may be able to join if you are at least 18 years old, have a good performance status (meaning you can do most daily activities), and your cancer has specific biomarkers (like BRCA or HRD positive). The main goals are to find out how safe the combination is and to determine the best dose of Cirtuvivint to use with Olaparib. Researchers will measure safety and dose over 6 months. The study is currently recruiting about 50 participants.

Study design
This is a Phase 1 study, meaning it's an early-stage trial. It will involve about 50 women and will look at different ways of taking Cirtuvivint in combination with Olaparib.
What's involved
You will visit the clinic often at the beginning for exams, blood tests, and other procedures. After two months, you will visit every 28 days. You will take Olaparib every day and Cirtuvivint either 5 days per week or 2 days per week.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study, safety and dose, are measured at 6 months. It is not specified how long participants are followed after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06856499

Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Colorado, Denver
~50 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:CirtuvivintOlaparib

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the Safety of Combination Cirtuvivint with Olaparib
Measured over 6 months
+1 more outcome measured

Conditions

Endometrioid Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerBRCA Gene FamilyTBCE wt Allele

Where it's being run

2 sites across 1 states
Colorado2

Study leadership

  • Bradley Corr · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Kailey Palmen, BA
[email protected]
303-724-2435
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have received at least one prior platinum-based chemotherapy regimen
Patients may not have received more than 3 prior lines of systemic therapy
Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy
Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)
Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
Prior radiation is allowed and is not considered a line of treatment 9. Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRD testing, and have been positive for one and/or the other. 10. Patients must have received a prior PARP inhibitor as either treatment or maintenance therapy 11. Patients must have adequate hematologic, liver, and kidney function as defined as:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL)
Platelet count ≥ 100 x 109/L (100,000 µL)
Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test
Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN
Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)
Serum albumin ≥ 2 g/dL 12. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 13. Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible.

Exclusion

Uncontrolled major seizure disorder
Unstable spinal cord compression
Any psychiatric disorder that prohibits obtaining informed consent.
Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of therapy 6. Patients with clinically significant cardiac disease including, but not limited to, any of the following
Myocardial infarction ≤ 6 months prior to first dose
Uncontrolled ventricular arrhythmia, recent (within 3 months)
Superior vena cava syndrome
Unstable angina pectoris
Uncontrolled congestive heart failure (New York Heart Association \> class II)
Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
Uncontrolled cardiac arrhythmias 7. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment 8. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C) 9. Persistent toxicities (\>/= Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensory neuropathy 10. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication

What this trial measures

  • Determine the Safety of Combination Cirtuvivint with Olaparib6 months

    To determine the safety and tolerability of combination Cirtuvivint and Olaparib in BRCA/HRD platinum resistant ovarian cancer as evaluated by CTCAE v5.0 criteria.

  • Determine the recommended Phase 2 Dose of Cirtuvivint with Olaparib6 months

    To determine the recommended Phase 2 Dose (RP2D) and regimen of the combination therapy