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NCT00159484 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00159484: Completed Phase 1 study, sponsored by University of Southern California.
NCT00159484 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00159484, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reproducing. Celebrex is a drug that is approved by the FDA for the treatment of arthritis and prevention of colon polyps. Colon polyps are small growths in the colon. If not surgically removed, some colon polyps can become cancerous. Some studies have shown that Celebrex may reduce the side effects of chemotherapy. Other studies have shown that it may increase the effectiveness of some chemotherapy. Celebrex is not approved by the FDA for reducing the side effects of chemotherapy or improving the effectiveness of chemotherapy. The combination of EPO906 and Celebrex in this study is experimental. The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will decrease the amount of diarrhea seen in patients that receive EPO906. The goal of the first phase of this study is to find the highest dose of EPO906 that can be given safely with Celebrex. The dose of Celebrex will remain the same for the whole study. Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will stop once more than one patient has serious side effects. The highest dose of EPO906 that can be given with Celebrex (without serious side effects) will be called the pilot dose. The goal of the second phase of this study is to find out how tumors respond to these doses of the drugs. Another purpose of this study is to see how the body processes the EPO906 and Celebrex. This study will also look at the side effects of these drugs. In this study, we will measure how long subjects live, how often tumors shrink after receiving the study drugs, and how long it takes for tumors to increase in size after receiving the study drugs. This study will also measure th
Primary Outcome
To determine the maximum tolerated dose (MTD) of Celebrex in combination with EPO906 in patients with metastatic colorectal cancer. The MTD is the highest dose that produces the desired therapeutic effect without causing unacceptable or dose-limiting side effects.
Interventions
- DRUG Celecoxib
- DRUG EPO906
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-10-12 |
| Est. Completion | 2023-03-23 |
| Phase | Phase 1 |
What the finished NCT00159484 record still lists
NCT00159484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Celecoxib is the first listed.
NCT00159484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00159484 about?
NCT00159484 is a clinical study titled "Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer". This study is for people with advanced colorectal cancer. This study uses the drugs Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA. EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reprod...
What is the current status of trial NCT00159484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2004-10-12. Estimated completion is 2023-03-23.
What interventions are being tested in trial NCT00159484?
The interventions under investigation include: Celecoxib (DRUG), EPO906 (DRUG).
Who is sponsoring clinical trial NCT00159484?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00159484's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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