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PARP Inhibitor
Niraparib for Esophageal and Stomach Cancer
Phase 2
Waitlist Available
Research Sponsored by Shadia Jalal, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 14 days prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is for patients with locally advanced or metastatic disease who have either somatic or germline mutations. Patients will be treated with niraparib every day until disease progression, unacceptable side effects, withdrawal of consent, or death.
Who is the study for?
Adults over 18 with advanced esophageal, gastroesophageal junction, or proximal gastric adenocarcinoma that's worsened after platinum-based chemotherapy can join. They must have specific genetic changes in their cancer cells and be well enough for daily activities (ECOG 0-1). Prior treatments should be completed with side effects resolved. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing Niraparib, an oral medication taken daily for patients whose cancer has certain genetic alterations. The treatment continues until the disease progresses, side effects become too severe, consent is withdrawn, or death occurs. Patients are monitored every two months using CT scans to assess the drug's effectiveness.See study design
What are the potential side effects?
Niraparib may cause fatigue, blood cell count issues (like anemia), nausea or vomiting, constipation or diarrhea, heart palpitations and could affect fertility. It might also lead to more serious conditions like high blood pressure or bone marrow problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been mostly active and able to carry on all pre-disease activities without restriction recently.
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I am willing to follow the study's rules on preventing pregnancy or fathering a child.
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My cancer can be measured by scans or physical exam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Assess adverse events
Disease Control Rate
Progression free survival
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%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Trial Design
1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
Shadia Jalal, MDLead Sponsor
2 Previous Clinical Trials
63 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,409 Total Patients Enrolled
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
142,750 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a PARP inhibitor before.I understand and can follow the study's procedures.I haven't had a blood transfusion in the last 4 weeks.I am 18 years old or older.I haven't had significant radiation therapy affecting my bone marrow in the last 2 weeks.My recent tests show my organs are functioning well.I've had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I have been mostly active and able to carry on all pre-disease activities without restriction recently.I have had only one chemotherapy for my advanced cancer but may have had other treatments.My cancer got worse within 2 months of starting standard platinum chemotherapy.I finished my last cancer treatment over 14 days ago and have recovered from its side effects.I haven't taken any immune system boosting drugs in the last 4 weeks.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I am willing to follow the study's rules on preventing pregnancy or fathering a child.I agree not to donate blood during the study or for 90 days after the last treatment.I do not have any other ongoing cancer.I do not have any serious health issues that are not under control.My cancer comes from the esophagus or upper stomach and has worsened after platinum-based treatment.I have a specific harmful gene change linked to cancer.My cancer can be measured by scans or physical exam.You are not allergic to the ingredients in niraparib or any other substances it contains, like tartrazine.I haven't taken any experimental drugs within the last 4 weeks or 5 half-lives of the drug, whichever is shorter.I had brain metastasis treatment over 4 weeks ago, am off steroids for 2 weeks, and have no symptoms.I have never been diagnosed with MDS or AML.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can this treatment be deleterious for patients?
"Clinical trials have yet to generate evidence of this treatment's efficacy, resulting in a safety rating of 2."
Answered by AI
What other types of research have been done regarding this therapeutic intervention?
"Initially studied in 2016, GSK Investigational Site has since been the site of 17 completed trials and 99 active studies concerning this treatment. A significant portion of these clinical investigations are ongoing at Buffalo, New york."
Answered by AI
What is the current capacity of this research project?
"Confirmed. As per the clinicaltrials.gov listing, this medical research is presently looking for individuals to enroll in their study, first posted on July 9th 2019 and recently updated May 23rd 2022. A total of 43 patients are being accepted across 3 participating locations."
Answered by AI
Is this an unprecedented research endeavor?
"Research into this specific remedy has been ongoing since 2016 when Myriad Genetics, Inc. kicked off the first trial with 733 participants. This drug was approved for Phase 3 use following that initial study and now there are 99 active trials taking place in 485 cities over 49 nations."
Answered by AI
Are there opportunities for participants in this current investigation?
"Affirmative. According to the clinicaltrials.gov database, this trial is still actively seeking participants after being initially posted on July 9th 2019 and updated most recently on May 23rd 2022. The study aims to recruit 43 patients from 3 distinct locations."
Answered by AI
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