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Niraparib for Soft Tissue Sarcoma
Study Summary
This trial will test the effectiveness of niraparib against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. It will also study the safety and side-effects of niraparib.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT03207347Trial Design
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Who is running the clinical trial?
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- I am not allergic to the study drug or its ingredients.I have been treated with a PARP inhibitor before.I practice abstinence as my form of birth control.I do not have any uncontrolled illnesses or infections needing ongoing treatment.I have a history or current diagnosis of MDS or AML.I have not had major surgery in the last 3 weeks.I agree not to donate blood during and for 3 months after the study.My organs are functioning well enough to start treatment.I haven't had radiation therapy on more than 20% of my bone marrow in the last 2 weeks.I have brain complications from cancer, like swelling or bleeding.I have an active tuberculosis infection.I have had a stem cell or organ transplant in the past.I have chronic HBV but am on treatment to control it before starting cancer therapy.I am being treated for HCV and my viral load is undetectable.I can take care of myself but might not be able to do heavy physical work.My condition worsened after at least one treatment.I have been on a stable dose of corticosteroids for at least 4 weeks.I have a stomach or intestine condition that could affect how drugs work in my body.I have received colony stimulating factors within the last 4 weeks.I am HIV-positive, on effective treatment, with undetectable virus and CD4 count ≥350.I am not pregnant or breastfeeding.I have had a blood transfusion within the last 4 weeks.I have active hepatitis B or C.I am 18 years old or older.My cancer has a harmful change in a DNA repair gene.I finished any cancer treatments or trials at least 4 weeks ago.My blood pressure is normal or well-managed with treatment.I've had severe blood-related side effects from recent chemotherapy that lasted more than 4 weeks.I have recovered from major side effects of my previous cancer treatment, except for hair loss and stable nerve pain.My sarcoma cannot be surgically removed and has spread.I agree to use effective birth control and not breastfeed during and for 6 months after the study.I agree to use effective birth control during and for 3 months after the study.
- Group 1: Niraparib
- 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
Has Niraparib been cleared by the FDA?
"Since this is a phase 2 trial, meaning that while there is some evidence of safety, there is none for efficacy, we have rated Niraparib as a 2 in terms of safety."
What is the projected scope of this clinical trial in terms of participants?
"The information available on clinicaltrials.gov seems to suggest that this study is still open to enrolling patients. This trial was originally posted on August 23rd, 2022 and was last updated September 7th, of the same year. The researchers conducting this study hope to recruit 32 participants from 7 different locations."
Are there any participants still needed for this research?
"That is correct, the online information shows that the trial is open and looking for volunteers. The listing went up on 8/23/2022 and was updated most recently on 9/7/2022. They need 32 people in total and have 7 different centres where patients can be recruited from."
In how many different areas is this investigation being conducted today?
"Currently, there are 7 active sites for this research study. They are situated in Basking Ridge, Middletown and New york amongst other places. To limit the amount of travel needed, please choose the site closest to your location."
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