NCT00040391 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Pan CX, Loehrer P, Seitz D, Helft P, Juliar B, Ansari R, Pletcher W, Vinson J, Cheng L, Sweeney C
A phase II trial of irinotecan, 5-fluorouracil and leucovorin combined with celecoxib and glutamine as first-line therapy for advanced colorectal cancer. Oncology. 2005;69(1):63-70.

A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer

Details for clinical trial NCT00040391

Clinical trial NCT00040391 - References