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Niraparib + Everolimus for Ovarian Cancer
Study Summary
This trial looks at combining two drugs to treat ovarian and breast cancer. The goal is to see if the combination is feasible and tolerated by patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 122 Patients • NCT02657889Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I agree to use birth control from the start of the study for at least 180 days after the last dose.I have not had radiation on more than 20% of my bone marrow.I haven't had major surgery in the last 3 weeks and have recovered from any past surgeries.I haven't had severe blood-related side effects or extreme tiredness from cancer treatment for more than 4 weeks.My ovarian cancer is resistant to platinum-based treatments, and I've had surgery for it.I am not allergic to niraparib, everolimus, rapamycin, or their ingredients.I am not immunocompromised, but I may have had my spleen removed.I don't have any health issues that would affect the study or stop me from fully participating.I have never been treated with or participated in a study involving PARP inhibitors.My blood tests show my organs are working well.I am currently taking ACE inhibitors.I have advanced gynecologic cancer and have tried or can't undergo all proven treatments.My breast or gynecologic cancer is not responding to current treatments.I can take care of myself and am up and about more than half of my waking hours.I am a woman who can have children and my pregnancy test was negative.I agree to use birth control before, during, and for 6 months after the study.I haven't been treated for any cancer other than skin cancer in the last 2 years.I don't have lasting side effects from cancer treatment worse than Grade 2.I haven't had a blood transfusion in the last 4 weeks.My blood pressure is not well controlled.My breast cancer is HER2 positive based on standard tests.I am not on strong or moderate drugs that affect drug metabolism.I do not have any serious, uncontrolled health issues or infections.My breast cancer can be measured by standard criteria, or I have ovarian cancer which may or may not be measurable.I do not have brain or spinal cord cancer spread.I have never been diagnosed with MDS or AML.I am not pregnant, breastfeeding, or planning to become pregnant during the study.
- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What other empirical studies have been done with niraparib?
"As of now, there are 191 trials ongoing which analyse the effects of niraparib. Of these, 29 have made it to Phase 3 and 6841 sites around the world are contributing to this research endeavour. Richmond Virginia is a major hub for such investigations."
What is the overall participation rate in this clinical experiment?
"Unfortunately, this trial has closed and is no longer accepting patients. The initial posting was on July 17th 2017 with the last update made on August 24th 2021. Those wishing to find other opportunities can explore 2921 clinical trials for breast cancer or 191 studies utilizing niraparib currently recruiting participants."
What medical condition is niraparib typically indicated for?
"Niraparib is regularly prescribed as a kidney transplant rejection treatment, but it also serves to alleviate the symptoms of waldenstrom macroglobulinemia, lung cancer and advanced carcinoid tumor."
Is this experiment currently open for enrollment?
"Unfortunately, this clinical trial is not currently open to recruitment. It was originally published on July 17th 2017 and last edited August 24 2021. If you are still searching for other studies, there are presently 2921 trials actively seeking participants with breast cancer diagnoses as well as 191 studies that admit patients taking niraparib."
Does niraparib have any potentially harmful side effects?
"The safety of niraparib is estimated to be 1 as this drug is in Phase 1 testing. There are only preliminary data confirming its efficacy and limited information available regarding any potential side effects."
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