Is NCT06856499 recruiting in Aurora, CO?

Yes, NCT06856499 is currently recruiting participants at its Aurora, CO location. This endometrioid ovarian cancer clinical trial is actively enrolling qualified participants.

How do I join the endometrioid ovarian cancer clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Endometrioid Ovarian Cancer Clinical Trial in Aurora, CO

About This Endometrioid Ovarian Cancer Study in Aurora

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.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

Provision to sign and date the consent form.

Stated willingness to comply with all study procedures and be available for the duration of the study.

Woman aged ≥18 years of age

Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2

Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

Patients must have platinum-resistant disease defined as radiographic progression less 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 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

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.

Patients must have received a prior PARP inhibitor as either treatment or maintenance 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 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

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.

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 Criteria

Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal type ovarian tumor

Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy

Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia.

Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, 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 weeks prior 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 to enrollment

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 sensory neuropathy

Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication o Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

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 and patients 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 investigators discretion.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06856499) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Endometrioid Ovarian Cancer Treatment Options in Aurora, CO

If you're searching for endometrioid ovarian cancer treatment options in Aurora, CO, this clinical trial (NCT06856499) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced endometrioid ovarian cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all endometrioid ovarian cancer clinical trials near you to find additional studies recruiting in your area.

Endometrioid Ovarian Cancer Clinical Trial in Aurora, CO

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