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Trial Summary


Protocol No.ESO17-325
StatusOPEN TO ACCRUAL
Principal InvestigatorJalal, Shadia
ScopeLocal
PhasePhase II
Age GroupAdult
TitleA Phase II Study Evaluating Safety and Efficacy of Niraparib in Patients with Previously Treated Homologous Recombination (HR) Defective or Loss of Heterozygosity (LOH) high Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
DescriptionPatients 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • A subject with symptomatic brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off corticosteroids for greater than or equal to 2 weeks, and are asymptomatic. Patients with asymptomatic brain mets that are untreated will be allowed.
  • Must not have received more than 1 prior line of chemotherapy in the metastatic setting (could have received immunotherapy, VEGF directed therapy, and/or trastuzumab which does not count as chemotherapy).
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesEsophagus
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu