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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. 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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01198535
The ClinicalTrials.gov registry entry for NCT01198535 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 60 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 4 interventions - of which Cetuximab is the first listed.
NCT01198535 reports 0 study locations.
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.
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