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NCT01238133 · ClinicalTrials.gov registry record · Phase 1
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage II or Stage III Triple-Negative Breast Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01238133: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01238133 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01238133, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and the best dose of gamma-secretase inhibitor RO4929097 when given together with paclitaxel and carboplatin in patients with stage II or stage III triple-negative breast cancer. Gamma-secretase inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs use in chemotherapy, such as paclitaxel and carboplatin, 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 gamma-secretase inhibitor RO4929097 together with paclitaxel and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- OTHER Pharmacological Study
- DRUG Gamma-Secretase Inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
Why NCT01238133 stopped before completion
NCT01238133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01238133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01238133 about?
NCT01238133 is a clinical study titled "Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage II or Stage III Triple-Negative Breast Cancer". This phase I trial studies the side effects and the best dose of gamma-secretase inhibitor RO4929097 when given together with paclitaxel and carboplatin in patients with stage II or stage III triple-negative breast cancer. Gamma-secretase inhibitor RO4929097 may stop the growth of tumor cells by blo...
What is the current status of trial NCT01238133?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2010-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01238133?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Pharmacological Study (OTHER), Gamma-Secretase Inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01238133?
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 NCT01238133's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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