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NCT01103375 · ClinicalTrials.gov registry record · Phase 1
Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01103375: Clinical Trial Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT01103375 is a Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103375, a Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help cells that are involved in the body's immune response to work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor cells
Primary Outcome
At least 3 patients will be treated at each dose level and the maximum tolerated dose (MTD) will be determined. Patients will be evaluated for dose-limiting toxicity (DLT) in the first 3 weeks on protocol.
Interventions
- GENETIC protein expression analysis
- OTHER laboratory biomarker analysis
- DRUG erlotinib hydrochloride
- DRUG isotretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
Why NCT01103375 stopped before completion
NCT01103375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which protein expression analysis is the first listed.
NCT01103375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103375 about?
NCT01103375 is a clinical study titled "Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma". This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin ...
What is the current status of trial NCT01103375?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-05. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01103375?
The interventions under investigation include: protein expression analysis (GENETIC), laboratory biomarker analysis (OTHER), erlotinib hydrochloride (DRUG), isotretinoin (DRUG).
Who is sponsoring clinical trial NCT01103375?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01103375's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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