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NCT03193437 · ClinicalTrials.gov registry record · Phase 2
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT03193437: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT03193437 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03193437, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (25 patients): There are two study arms: Arm A: Thymoma * Stage 1: 15 patients * Stage 2: 10 patients Arm B: Thymic carcinoma * Stage 1: 15 patients * Stage 2: 10 patients
Primary Outcome
To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.
Interventions
- DRUG Open Label Selinexor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2022-01-31 |
| Phase | Phase 2 |
Why NCT03193437 stopped before completion
NCT03193437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Open Label Selinexor is the first listed.
NCT03193437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03193437 about?
NCT03193437 is a clinical study titled "Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy". The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adu...
What is the current status of trial NCT03193437?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-04-03. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT03193437?
The interventions under investigation include: Open Label Selinexor (DRUG).
Who is sponsoring clinical trial NCT03193437?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03193437's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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