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NCT01071564 · ClinicalTrials.gov registry record · Phase 1
RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01071564: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01071564 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01071564, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with vismodegib in treating patients with breast cancer that is metastatic or cannot be removed by surgery. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving RO4929097 and vismodegib together may slow the growth of tumor cells and may be a more active treatment for advanced breast cancer.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Vismodegib
- OTHER Pharmacological Study
- OTHER Pharmacogenomic Study
- DRUG Gamma-Secretase Inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
Why NCT01071564 stopped before completion
NCT01071564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01071564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01071564 about?
NCT01071564 is a clinical study titled "RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery". This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with vismodegib in treating patients with breast cancer that is metastatic or cannot be removed by surgery. RO4929097 may stop the growth of tumor...
What is the current status of trial NCT01071564?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2009-11. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01071564?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Vismodegib (DRUG), Pharmacological Study (OTHER), Pharmacogenomic Study (OTHER), Gamma-Secretase Inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01071564?
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
How this trial's enrollment target compares
Where NCT01071564's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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