Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01217411 · ClinicalTrials.gov registry record · Phase 1
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01217411: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01217411 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01217411, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic radiosurgery and to see how well it works compared to whole-brain radiation therapy or stereotactic radiosurgery alone in treating patients with breast cancer or other cancers (such as lung cancer or melanoma) that have spread to the brain. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Whole-brain radiation therapy uses high energy x-rays deliver radiation to the entire brain to treat tumors that can and cannot be seen. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether giving RO4929097 together with whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor cells.
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Stereotactic Radiosurgery
- PROCEDURE Cognitive Assessment
- RADIATION Whole-Brain Radiotherapy
- DRUG Gamma-Secretase Inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-10-01 |
| Est. Completion | 2011-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01217411
The ClinicalTrials.gov registry entry for NCT01217411 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01217411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01217411 about?
NCT01217411 is a clinical study titled "RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer". This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic radiosurgery and to see how well it works compared to whole-brain radiation t...
What is the current status of trial NCT01217411?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-10-01. Estimated completion is 2011-11-30.
What interventions are being tested in trial NCT01217411?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Stereotactic Radiosurgery (RADIATION), Cognitive Assessment (PROCEDURE), Whole-Brain Radiotherapy (RADIATION), Gamma-Secretase Inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01217411?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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, the data changelog, or report a data error.