A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
TerminatedPhase 2Results postedLast updated 4 June 2024
What this trial tests
Phase 2 trial testing Niraparib in Esophageal Cancer in 14 participants. Terminated before completion.
18 and older, any sex, with Esophageal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· Up to maximum of 5 months.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
ORR is defined as the percentage of patients who reached CR or PR by RECIST 1.1.
Group
Value
95% CI
Niraparib
0
Adverse EventsSecondary· AE had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 6 months.
Number of participants with treatment related adverse events are reported by CTCAEv5 term and grade.
Anemia
Group
Value
95% CI
Niraparib
7
Fatigue
Group
Value
95% CI
Niraparib
7
Platelet count decreased
Group
Value
95% CI
Niraparib
7
Nausea
Group
Value
95% CI
Niraparib
6
Headache
Group
Value
95% CI
Niraparib
5
White blood cell decreased
Group
Value
95% CI
Niraparib
5
Anorexia
Group
Value
95% CI
Niraparib
3
Constipation
Group
Value
95% CI
Niraparib
3
Progression Free Survival (PFS)Secondary· Up to a maximum of 5 months.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
PFS is defined as time from treatment start until disease progression met by RECIST 1.1 or death from any cause.
Group
Value
95% CI
Niraparib
1.8
1 – 3.7
Disease Control RateSecondary· Up to maximum of 5 months.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
Disease control rate (DCR) is defined as the percentage of evaluable patients with stable disease (SD) for 8 weeks, or partial response (PR), or complete response (CR) according to RECIST 1.1.
Group
Value
95% CI
Niraparib
18.2
2.3 – 51.8
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
· Phase 4
· recruiting
NCT06682780 — A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
· Phase 1, PHASE2
· recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo
· Phase 3
· recruiting
NCT06887933 — A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ov
· Phase 4
· not yet recruiting
NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
· Phase 1, PHASE2
· withdrawn
Other recruiting trials for Esophageal Cancer
Currently open trials in the same condition.
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers
· recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta
· Phase 3
· recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer
· active not recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
· NA
· recruiting
Other Shadia Jalal, MD trials
Trials by the same sponsor.
NCT03913455 — Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer
· Phase 2
· completed
NCT02639065 — A Study of Durvalumab (MEDI4736) in Esophageal Cancer
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shadia Jalal, MD
Last refreshed: 4 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03840967.