Phase
Condition
Fallopian Tube Cancer
Pelvic Cancer
Ovarian Cysts
Treatment
Cirtuvivint
Olaparib
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for theduration of the study.
Woman aged ≥18 years of age
Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 1 or 2
Patients must have a confirmed diagnosis of high-grade serous or endometrioidepithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Patients must have platinum-resistant disease defined as radiographic progressionless than 6 months from last dose of most recent platinum therapy
Patients must have measurable disease by defined RECIST 1.1 criteria
Prior anticancer therapy:
Patients must have received at least one prior platinum-based chemotherapyregimen
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 partof preceding line of therapy (ie, not counted independently)
Therapy changed due to toxicity in the absence of progression will beconsidered part of the same line (ie, not counted independently)
Hormonal therapy will be counted as a separate line of therapy unless it wasgiven as maintenance
Prior radiation is allowed and is not considered a line of treatment
Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRDtesting, and have been positive for one and/or the other.
Patients must have received a prior PARP inhibitor as either treatment ormaintenance therapy
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 theCockcroft-Gault equation or based on a 24 hour urine test
Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic PyruvateTransaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in whichcase they must be ≤ 5x ULN
Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbertsyndrome are eligible if total bilirubin < 3.0 x ULN)
Serum albumin ≥ 2 g/dL
Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial.
Ability to understand and the willingness to sign a written informed consentdocument. Participants with impaired decision-making capacity (IDMC) who have alegally-authorized representative (LAR) and/or family member available will also beeligible.
Exclusion
Exclusion Criteria:
Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, orsex-cord stromal type ovarian tumor
Patients with platinum refractory disease as defined by those who have progressedduring or within 4 weeks of receiving platinum-based therapy
Patients receiving any systemic chemotherapy or radiotherapy (except for palliativereasons) within 3 weeks prior to study treatment
Patients with myelodysplastic syndrome/acute myeloid leukemia or with featuressuggestive of myelodysplastic syndrome/acute myeloid leukemia.
Patients considered a poor medical risk due to a serious, uncontrolled medicaldisorder, non-malignant systemic disease or active, uncontrolled infection. Examplesinclude, but are not limited to:
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 weeksprior to the first dose of therapy
- 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
Patients with a history of hemorrhagic or ischemic stroke within 6 months prior toenrollment
Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
Persistent toxicities (>/= Common Terminology Criteria for Adverse Event (CTCAE)grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensoryneuropathy
Patients with duodenal stent or other GI disorder/defect that would interfere withabsorption of oral medication o Includes patients unable to swallow orally administered medication and patientswith gastrointestinal disorders likely to interfere with absorption of the studymedication
Patients with known untreated or symptomatic central nervous system (CNS) metastases
Prior known hypersensitivity reaction to study drugs and/or any of their excipients
Minor or major surgical procedure within 2 weeks of starting study treatment andpatients must have recovered from any effects of any major surgery.
Inability to comply with study and follow-up procedures
Patients deemed otherwise clinically unfit for clinical trial per investigatorsdiscretion.
Study Design
Study Description
Connect with a study center
CU Medicine Clinics
Aurora, Colorado 80045
United StatesSite Not Available
Universtiy of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
CU Medicine Clinics
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Universtiy of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.