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: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT04541407 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Adverse events will be determined by the common terminology criteria for adverse events version 5.0
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 |
What the finished NCT04541407 record still lists
NCT04541407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide plus Osimertinib is the first listed.
NCT04541407 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04541407's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI