Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04854434 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations
A Phase 2 study, sponsored by Karyopharm Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04854434 is a Phase 2 study that was terminated before completion, run by Karyopharm Therapeutics. The registered enrollment target is 13 participants.
The verdict
NCT04854434, a Phase 2 study, was terminated before completion, sponsored by Karyopharm Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (selinexor only), B (selinexor and pembrolizumab), and C (standard of care \[Combination of trifluridine and tipiracil\]). Randomization will be based on stratification factors: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 versus 2. The end of treatment (EoT) visit will occur less than or equal to (\<=30) days post-treatment discontinuation. A survival follow-up visit will be performed every 3 months from EoT and will continue for 12 months.
Interventions
- DRUG Pembrolizumab
- DRUG Selinexor
- DRUG Trifluridine
- DRUG Tipiracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2022-06-24 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04854434
The ClinicalTrials.gov registry entry for NCT04854434 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04854434 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04854434 about?
NCT04854434 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations". The purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (sel...
What is the current status of trial NCT04854434?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-06-29. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT04854434?
The interventions under investigation include: Pembrolizumab (DRUG), Selinexor (DRUG), Trifluridine (DRUG), Tipiracil (DRUG).
Who is sponsoring clinical trial NCT04854434?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.