BridgeMD
New treatment option for Ovarian Cancer
Official title Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer
ClinicalTrials.gov ID: NCT05961124
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Also referred to as Zejula.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are: What is the incidence of hematologic and other adverse events?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must be able to understand the study, agree to participate and provide written, informed consent
- Patients must be female and age \>/= 18 years of age
- Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer...
- Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing...
- Patients must meet the following front-line treatment requirements: i. Patients must have completed a minimum of 4 cycles of platinum-based...
You likely can't join if
- Patient's age is \<18 years.
- Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study...
- Patients with a known hypersensitivity to niraparib or any of its components
- Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a...
- Patients enrolled in another investigational trial
- Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer
See the full eligibility criteria
Who can join
- Patients must be able to understand the study, agree to participate and provide written, informed consent
- Patients must be female and age \>/= 18 years of age
- Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment
- Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing neoadjuvant chemotherapy (NACT)
- Patients must meet the following front-line treatment requirements: i. Patients must have completed a minimum of 4 cycles of platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin). Primary or interval...
- CA-125 in normal range or
- CA-125 decreased by 90% during front-line treatment and stable for a minimum of 7 days (does not increase by more than 15%) iv. Study drug can start within 12 weeks of completing chemotherapy
- Patients must be post-menopausal with no menses for \>1 year, or surgically sterilized, or willing to use adequate contraception to prevent pregnancy or abstain from intercourse and agrees not to donate eggs for the...
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Patients must have adequate organ function at enrollment, as follows: i. Absolute neutrophil count \>/= 1.5 x109/L ii. Platelets \>/= 100 x109/L iii. Hemoglobin \>/= 100 g/L without transfusion iv. Creatinine clearance...
- Patients with hypertension should have their blood pressure adequately treated and controlled prior to starting study treatment
- Patients must be able to take oral medications
- Patients must agree to complete blood samples prior to cycle 1, then weekly for the first month and as outlined in the protocol
What rules you out
- Patient's age is \<18 years.
- Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment.
- Patients with a known hypersensitivity to niraparib or any of its components
- Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial.
- Patients enrolled in another investigational trial
- Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer
- Patients with previous persistent (\>4 weeks) or \>/= grade 3 hematologic toxicity or fatigue from prior cancer therapy.
- Patients with known history of myelodysplastic syndrome or pre-treatment cytogenetic testing at risk for myelodysplastic syndrome or acute myeloid leukemia
- Patients receiving concurrent, prohibited medications
- Patients with previous major surgery within 3 weeks of starting study treatment and must have recovered from any effects of previous surgery.
- Patients with ascites drained within 4 weeks of starting study treatment
- Patients receiving palliative radiotherapy to \>20% of bone marrow within 2 weeks or any other radiotherapy within 1 week of study treatment
- Patients receiving a transfusion (platelets or red blood cells) within 4 weeks of treatment
- Patients planning to donate blood during the study or 90 days after treatment.
- Patients with a diagnosis of another invasive cancer (other than ovarian cancer), within 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated i. Patients...
- No new or progressive signs or symptoms, stable steroid dose x 4 weeks or not taking steroids
- Patients considered poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection i. Patients with known HIV considered high risk for serious and fatal...
- Patients with evidence of any condition, therapy, or laboratory abnormality that might confound study results or patient participation for full duration of study (Ex. Myelodysplastic syndrome, anemia, leukopenia...
- Patients who are immunocompromised (Patients with splenectomy are allowed)
- Patients with known, active hepatic disease (Ex. Hepatitis B or C), active biliary disease (exceptions for Gilbert's syndrome, asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease as per...
- Patients with QT prolongation \>470 milliseconds at screening
- Patients with a known breast cancer susceptibility gene (BRCA1 and 2) mutation (as they routinely receive olaparib at our institution) If BRCA unknown they are not excluded.
- Patients with a history of posterior reversible encephalopathy syndrome (PRES)
- Patients who have had a live vaccine within 30 days of planned start date of study treatment
- Patients with gastrointestinal abnormalities that may limit absorption
- Patients with significant cardiovascular disease
- Patients undergoing serial blood counts to achieve a value to meet eligibility
- Patients receiving blood product transfusions in order to meet eligibility criteria
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.