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:

🇪🇺 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

🇺🇸 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

🇨🇦 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