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PARP Inhibitor
Niraparib for Soft Tissue Sarcoma
Phase 2
Waitlist Available
Led By William Tap, MD
Research Sponsored by Memorial Sloan Kettering Cancer 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 2 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Adults with certain types of soft tissue or uterine sarcoma that can't be surgically removed and have spread, who've tried at least one other cancer treatment. They must have specific genetic changes in their tumor DNA related to the DDR pathway, measurable disease, good organ function, and a performance status indicating they can care for themselves. Women must not be pregnant and agree to contraception; men also need to use birth control.
What is being tested?
The trial is testing Niraparib's effectiveness on advanced soft tissue sarcomas with DDR mutations. It aims to find out if it's safe with mild side effects and if some genetic alterations respond better than others. Participants will receive Niraparib as the study drug.
What are the potential side effects?
While not explicitly listed here, common side effects of Niraparib may include nausea, fatigue, blood cell count issues (like anemia), heart palpitations, insomnia, mouth sores, muscle pain or weakness. Each person might experience these differently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Assess adverse events
Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dizziness
22%
Insomnia
22%
Dyspnea
22%
Abdominal pain
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Cough
9%
Dehydration
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Postnasal drip
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Peripheral sensory neuropathy
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Upper respiratory infection
4%
Hyperkalemia
4%
Leukocytosis
4%
White blood cell decreased
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Awards & 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: NiraparibExperimental Treatment1 Intervention
This study will utilize Simon's two-stage design: 16 patients will be enrolled in the first portion of this study. If 4 or more patients are progression-free at 12 weeks, an additional 16 patients will be enrolled for a total of n = 32 patients enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,720 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,807 Previous Clinical Trials
8,381,310 Total Patients Enrolled
William Tap, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
752 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: 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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