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NCT03095612 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT03095612: Clinical Trial Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT03095612 is a Phase 1 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095612, a Phase 1 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant lung cancer.
Primary Outcome
A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLTs were collected to determine the Maximum-Tolerated Dose (MTD). \*\*DLT will include the following when considered to be at least possibly related to study drug administration: 1) \> 1 missed doses (out of 4 doses) of study treatment during cycle 1 due to study treatment related toxicities 2) Discontinuation of study therapy before completion of Cycle 1, due to stud
Interventions
- DRUG Docetaxel
- DRUG Selinexor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2023-03-03 |
| Phase | Phase 1 |
Why NCT03095612 stopped before completion
NCT03095612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT03095612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03095612 about?
NCT03095612 is a clinical study titled "Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)". This study is being done to evaluate the safety of the investigational study drug, selinexor when given with docetaxel to patients who have been previously treated for advanced KRAS mutant lung cancer.
What is the current status of trial NCT03095612?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-03-22. Estimated completion is 2023-03-03.
What interventions are being tested in trial NCT03095612?
The interventions under investigation include: Docetaxel (DRUG), Selinexor (DRUG).
Who is sponsoring clinical trial NCT03095612?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03095612's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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