~2 spots leftby Mar 2026

Niraparib for Esophageal and Stomach Cancer

Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen ByShadia Jalal, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Shadia Jalal, MD
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?Patients can be prescreened for the study at the time of diagnosis of locally advanced or metastatic disease by determining presence of LOH high status and/or deleterious alterations in HR pathway genes in the most recent available tumor tissue sample or in blood if they are found to have germline mutations. Patients with either somatic or germline mutations will be allowed. At the time of disease progression, patients with high LOH or deleterious alterations in HR pathway genes and satisfying all other inclusion criteria will be enrolled on the study. Patients will be treated with niraparib (flat dose) orally every day for 28 days until disease progression, unacceptable side effects, withdrawal of consent, or death. CT of the chest/abdomen/pelvis will be performed every 2 months and response will be assessed by RECIST 1.1.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
I have been mostly active and able to carry on all pre-disease activities without restriction recently.
I am willing to follow the study's rules on preventing pregnancy or fathering a child.
My cancer can be measured by scans or physical exam.

Exclusion Criteria

I have been treated with a PARP inhibitor before.
I haven't had a blood transfusion in the last 4 weeks.
I haven't had significant radiation therapy affecting my bone marrow in the last 2 weeks.
I've had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.
I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.
I do not have any other ongoing cancer.
I do not have any serious health issues that are not under control.
I have never been diagnosed with MDS or AML.

Participant Groups

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.
1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment1 Intervention
Niraparib is already approved in European Union, United States, Canada for the following indications:
πŸ‡ͺπŸ‡Ί Approved in European Union as Zejula for:
  • Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
  • Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
πŸ‡ΊπŸ‡Έ Approved in United States as Zejula for:
  • Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
  • Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
πŸ‡¨πŸ‡¦ Approved in Canada as Zejula for:
  • Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
Indiana Univeristy Melvin and Bren Simon Cancer CenterIndianapolis, IN
University of Michigan Health SystemAnn Arbor, MI
Moffitt Cancer CenterTampa, FL
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Who is running the clinical trial?

Shadia Jalal, MDLead Sponsor
GlaxoSmithKlineIndustry Sponsor
Indiana University School of MedicineCollaborator

References