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NCT03840967 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
A Phase 2 study, sponsored by Shadia Jalal, MD.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03840967: Clinical Trial Phase 2 study, sponsored by Shadia Jalal, MD.
NCT03840967 is a Phase 2 study that was terminated before completion, run by Shadia Jalal, MD. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03840967, a Phase 2 study, was terminated before completion, sponsored by Shadia Jalal, MD.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 2 |
Why NCT03840967 stopped before completion
NCT03840967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Niraparib is the first listed.
NCT03840967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03840967 about?
NCT03840967 is a clinical study titled "A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma". 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 m...
What is the current status of trial NCT03840967?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2019-07-09. Estimated completion is 2023-02-22.
What interventions are being tested in trial NCT03840967?
The interventions under investigation include: Niraparib (DRUG).
Who is sponsoring clinical trial NCT03840967?
This trial is sponsored by Shadia Jalal, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03840967's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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