Is NCT06412120 recruiting in Fort Lauderdale, FL?

Yes, NCT06412120 is currently recruiting participants at its Fort Lauderdale, FL location. This ovarian cancer clinical trial is actively enrolling qualified participants.

How do I join the ovarian cancer clinical trial in Fort Lauderdale?

To join this clinical trial in Fort Lauderdale, 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 Fort Lauderdale 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.

Ovarian Cancer Clinical Trial in Fort Lauderdale, FL

About This Ovarian Cancer Study in Fort Lauderdale

The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.

Sponsor: University of Miami

Who Can Participate

Inclusion Criteria

Participant must be female ≥18 years of age, able to understand study procedures, and agree to participate in the study by providing written informed consent.

Self-identify as Black. Please note that individuals who identify as Latino are eligible to participate so long as they also self-identify as Black.

Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.

Participant must have high-grade serous or high-grade endometrioid histology.

Participant must provide saliva and/or blood specimens for assessment of germline mutation(s) in the Fanconi Anemia pathway.

Participant must provide formalin-fixed, paraffin-embedded (FFPE) or fresh tumor specimen from initial cytoreductive surgery (primary debulking) or initial pre-treatment core biopsy (if neoadjuvant chemotherapy (NACT) received; tumor obtained from interval cytoreduction acceptable if pre-treatment biopsy not obtained).

Participant must have had a complete or partial clinical response to adjuvant treatment as confirmed by CT scan within 8 weeks after completion of the last dose of platinum-based chemotherapy.

Participant must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments.

Participant must not have any known contraindication or hypersensitivity to niraparib or any of its excipients.

Participants must be considered candidates for maintenance niraparib therapy by their treating physician.

Participants should have adequate organ function as defined below:

Platelets ≥ 100 platelets × 10\^9/L

Hemoglobin ≥ 9 g/dL or 5.6 mmol/L

Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN), \<5× in patients with known liver metastases

Serum total bilirubin ≤ 1.5 × ULN

5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily.

Creatinine \<1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥50 mL/min by Cockcroft-Gault

Depending on scenario, glomerular filtration rate (GFR) 30-49 mL/min can be permissible.

Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:

Cluster of differentiation 4 (CD4) ≥350/μL and viral load \<400 copies/mL

No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months before enrollment

No history of HIV-associated malignancy for the past 5 years. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \>4 weeks before study enrollment.

A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:

Is not a woman of childbearing potential (WOCBP), or

Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year) from the Screening Visit through at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment, and

A WOCBP must have a negative test result from a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours before treatment. Additional periodic testing should be carried out according to the protocol. Note: The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

Participant must agree to complete HRQoL and patient reported outcomes (PRO) measures throughout the study period.

Exclusion Criteria

Any of the following histologies: low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, dedifferentiated

Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Primary progressive, platinum-refractory disease

Participant is at an increased risk of bleeding due to concurrent conditions (eg, major injuries or major surgery within the past 28 days before start of study treatment).

Current diagnosis of platelet disorder (eg, thrombotic thrombocytopenic purpura (TTP), immune thrombocytopenia (ITP))

Inability to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication

Participants that have systolic blood pressure (SBP\])\>140 mmHg or diastolic blood pressure (DBP)\>90 mmHg that has not been adequately treated or controlled.

Active second primary malignancy

Participant is pregnant, currently breastfeeding an infant, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.

Participant has received a live vaccine within 30 days of planned start of study therapy. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live viruses are allowed.

Participant has received a transfusion (platelets or red blood cells) or colony-stimulating factors (eg, granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks before the first dose of study treatment.

Participant has had radiotherapy encompassing \>20% of the bone marrow within 2 weeks or any radiation therapy within 1 week before Day 1 of protocol therapy.

Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastasis, or radiographic signs of central nervous system hemorrhage.

Participant has current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.

Participants with active hepatitis B or C infection.

Patient with prior history of posterior reversible encephalopathy syndrome (PRES).

Patients with impaired decision-making capacity.

Participants have high 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 ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.

Patient is currently receiving one or more cytotoxic, hormonal, or other medications to treat their cancer.

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 Fort Lauderdale?

Yes, this clinical trial (NCT06412120) has an active research site in Fort Lauderdale, FL 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.

Ovarian Cancer Treatment Options in Fort Lauderdale, FL

If you're searching for ovarian cancer treatment options in Fort Lauderdale, FL, this clinical trial (NCT06412120) 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 Fort Lauderdale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced 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 ovarian cancer clinical trials near you to find additional studies recruiting in your area.

Ovarian Cancer Clinical Trial in Fort Lauderdale, FL

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