A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Shadia Jalal, MD
Study ID
NCT03840967
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days

Study Details

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.

Key Dates

Start date
Jul 9, 2019
Status verified
May 2024
Primary completion
Nov 17, 2022
Completion
Feb 22, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Niraparib

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to maximum of 5 months. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Indiana Univeristy Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
University of Michigan Health SystemAnn ArborMichigan48109-
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Tampa, FL

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FLIndiana Univeristy Melvin and Bren Simon Cancer Center· Indianapolis, INUniversity of Michigan Health System· Ann Arbor, MIRoswell Park Cancer Institute· Buffalo, NY

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