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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.
Must not have
Prior therapy with a PARP inhibitor
Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to maximum of 5 months.
Awards & highlights
No Placebo-Only Group
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.
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 The treatment continues until the disease progresses, side effects become too severe, consent is withdrawn, or death occurs.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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a PARP inhibitor before.
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I haven't had a blood transfusion in the last 4 weeks.
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I haven't had significant radiation therapy affecting my bone marrow in the last 2 weeks.
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I've had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.
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I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.
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I do not have any other ongoing cancer.
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I do not have any serious health issues that are not under control.
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I have never been diagnosed with MDS or AML.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to maximum of 5 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to maximum of 5 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Adverse Events
Disease Control Rate
Progression Free Survival (PFS)
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%
Insomnia
22%
Abdominal pain
22%
Dizziness
22%
Dyspnea
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
13%
Vomiting
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Hypertension
9%
Cough
9%
Dry mouth
9%
Blood bilirubin increased
9%
Dehydration
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Back pain
4%
Hoarseness
4%
Hot flashes
4%
Hyponatremia
4%
Depression
4%
Diarrhea
4%
Hyperglycemia
4%
Hypotension
4%
Hypokalemia
4%
Hyperkalemia
4%
Head injury
4%
Bruising
4%
Edema limbs
4%
Esophageal ulcer
4%
Itchy eyes
4%
Flu like symptoms
4%
Oral petechia
4%
Leukocytosis
4%
Postnasal drip
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Tremor
4%
Skin tear
4%
Upper respiratory infection
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
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?
Shadia Jalal, MDLead Sponsor
2 Previous Clinical Trials
63 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,815 Previous Clinical Trials
8,384,176 Total Patients Enrolled
Indiana University School of MedicineOTHER
192 Previous Clinical Trials
179,393 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.