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Poly (ADP-ribose) Polymerase (PARP) Inhibitor
Niraparib + Selenium for Recurrent Ovarian Cancer
Phase 1 & 2
Waitlist Available
Led By Lorna Rodriguez-Rodriguez
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combo therapy of selenium and niraparib to treat BRCA-negative ovarian cancer that doesn't respond to standard treatment. Selenium blocks cancer growths, niraparib kills cancer cells.
Who is the study for?
This trial is for adults over 18 with recurrent BRCA negative ovarian cancer that's resistant to platinum therapy. Participants must have had no more than four prior chemo treatments, not be pregnant or breastfeeding, and agree to use effective birth control. They should have adequate organ function and blood counts, controlled blood pressure, and cannot have certain other medical conditions or recent treatments.
What is being tested?
The trial tests the safety and optimal dose of niraparib combined with selenium in treating patients whose ovarian cancer has returned and doesn't respond to platinum-based therapy. Niraparib is a PARP inhibitor which kills cancer cells; selenium may prevent growths from becoming cancerous.
What are the potential side effects?
Potential side effects include typical reactions associated with chemotherapy such as fatigue, nausea, digestive issues, blood cell count changes (anemia, neutropenia), possible allergic reactions to components of the treatment regimen, among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicity (Phase I)
Progression-free Survival (PFS) (Phase II)
Tolerability (Phase II)
Secondary study objectives
Disease Control Rate
Overall Response Rate (ORR)
Overall Survival (OS)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (selenium, niraparib)Experimental Treatment5 Interventions
Patients receive selenium IV and niraparib PO on study. Patients also undergo CT, MRI, biopsy, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Niraparib
2018
Completed Phase 4
~2400
Biopsy
2014
Completed Phase 4
~1090
Selenium
2003
Completed Phase 4
~60400
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,979 Total Patients Enrolled
289 Trials studying Ovarian Cancer
76,483 Patients Enrolled for Ovarian Cancer
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,535 Total Patients Enrolled
8 Trials studying Ovarian Cancer
271 Patients Enrolled for Ovarian Cancer
Lorna Rodriguez-RodriguezPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with MDS or AML.I haven't taken any colony-stimulating factors in the last 4 weeks.I have not taken UGT1A1 inhibitors in the last 14 days.I haven't had chemotherapy, biological therapy, or immunotherapy in the last 21 days.My kidney function, measured by creatinine levels or clearance, is within the required range.I haven't had radiation on more than 20% of my bone marrow in the last 2 weeks.My blood pressure is under control and does not exceed 160/90 mmHg.I am currently experiencing diarrhea.My genetic test shows no harmful BRCA mutations and no HRD.I have not taken herbal medications with selenium in the last 14 days.I am not pregnant or breastfeeding.I am 18 years old or older.I have not taken Vitamin E in the last 14 days.I have had PRES in the past.I have another active cancer besides the one being treated.I have a history of HIV or hepatitis B/C.I have had an organ or stem cell transplant.My cancer is confirmed in the ovary, fallopian tube, or peritoneum and is not a less aggressive or mucinous type.My cancer can be measured by scans or has visible signs on imaging.I have not received a blood transfusion in the last 4 weeks.I haven't taken strong CYP3A4 drugs in the last 14 days.I have severe anemia, low white blood cell or platelet counts from recent chemo that lasted over 4 weeks.I am capable of having children and have not been surgically sterilized.I haven't had treatment for another cancer type, except skin or treated cervical cancer, in the last 2 years.I do not have any uncontrolled illnesses or disorders that could affect my participation.I don't have active brain issues from cancer and haven't used steroids for them in the last 4 weeks.My cancer returned and got worse within 6 months after my last platinum-based treatment.I have recovered from side effects of cancer treatment, except for hair loss.My liver enzyme levels are within the required range for the trial.I have not received any live vaccines in the last 14 days, except for the seasonal flu shot.I haven't taken blood thinners in the last 14 days, except for ASA or NSAIDs.I do not have any active infections.I haven't had major surgery, except for ovarian cancer, in the last 3 weeks.I can perform all my self-care but may not be able to do heavy physical work.My blood pressure is normal or well-managed with medication.I have trouble taking pills due to swallowing problems or constant nausea.I have had 4 or fewer chemotherapy treatments. Hormone therapies and PARP inhibitors don't count.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selenium, niraparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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