Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04541407 · ClinicalTrials.gov registry record · Phase 1
Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04541407 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 1 participants.
The verdict
NCT04541407, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This trial is testing two novel combinations (temozolomide plus osimertinib OR temozolomide plus lorlatinib) which have not been evaluated in clinical trials. Thus, the exact benefits of these novel combinations are unclear. However, based on the mechanism of action of temozolomide and CNS(Central Nervous System) penetration/activity in other tumor types, it is hypothesized that adding temozolomide to osimertinib or temozolomide to lorlatinib may provide improvement in CNS disease control in patients with CNS progression on either of these latter two TKIs (Tyrosine kinase inhibitors).
Interventions
- DRUG Temozolomide plus Osimertinib
- DRUG Temozolomide plus Lorlatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04541407
The ClinicalTrials.gov registry entry for NCT04541407 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temozolomide plus Osimertinib is the first listed.
NCT04541407 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04541407 about?
NCT04541407 is a clinical study titled "Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease". This trial is testing two novel combinations (temozolomide plus osimertinib OR temozolomide plus lorlatinib) which have not been evaluated in clinical trials. Thus, the exact benefits of these novel combinations are unclear. However, based on the mechanism of action of temozolomide and CNS(Central N...
What is the current status of trial NCT04541407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-10-29. Estimated completion is 2022-06-07.
What interventions are being tested in trial NCT04541407?
The interventions under investigation include: Temozolomide plus Osimertinib (DRUG), Temozolomide plus Lorlatinib (DRUG).
Who is sponsoring clinical trial NCT04541407?
This trial is sponsored by University of Colorado, Denver, which has 1,283 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.