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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 is a Phase 2 study that was terminated before completion, run by Shadia Jalal, MD. The registered enrollment target is 14 participants.
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.
Interventions
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03840967
The ClinicalTrials.gov registry entry for NCT03840967 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shadia Jalal, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Niraparib is the first listed.
NCT03840967 reports 0 study locations.
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.
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