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NCT01198535 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Cetuximab With RO4929097 in Metastatic Colorectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01198535: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01198535 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198535, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a new drug, RO4929097, can work with cetuximab, a drug already approved for colorectal cancer, to help fight the patient's cancer. Cancers arise as a result of abnormal control of gene expression. One of the pathways that gets abnormally regulated in some cancers is the Notch pathway. RO4929097 is an investigational drug that blocks the activation of the Notch pathway. It is hoped that by blocking this abnormal activation, this drug may be helpful in patients with cancer but the investigators do not yet know if that is true. Cetuximab is an antibody against epidermal growth factor receptor and is known to have activity in metastatic colorectal cancer. Recent studies have shown that people with colorectal cancers that contain a mutation in a gene called K-ras do not benefit from receiving cetuximab. It is unknown if adding RO4929097 to cetuximab would benefit patients who have tumors with this mutation.
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Gamma-Secretase Inhibitor RO4929097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-09 |
| Phase | Phase 1 |
Why NCT01198535 stopped before completion
NCT01198535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Cetuximab is the first listed.
NCT01198535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01198535 about?
NCT01198535 is a clinical study titled "Phase I Study of Cetuximab With RO4929097 in Metastatic Colorectal Cancer". The purpose of this study is to determine if a new drug, RO4929097, can work with cetuximab, a drug already approved for colorectal cancer, to help fight the patient's cancer. Cancers arise as a result of abnormal control of gene expression. One of the pathways that gets abnormally regulated in some...
What is the current status of trial NCT01198535?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-09.
What interventions are being tested in trial NCT01198535?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Gamma-Secretase Inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01198535?
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 NCT01198535's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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