NCT01445405 - 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)

Hong WK, Lippman SM, Itri LM, Karp DD, Lee JS, Byers RM, Schantz SP, Kramer AM, Lotan R, Peters LJ, et al
Prevention of second primary tumors with isotretinoin in squamous-cell carcinoma of the head and neck. N Engl J Med. 1990 Sep 20;323(12):795-801.
Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ
Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66.
Kotwall C, Sako K, Razack MS, Rao U, Bakamjian V, Shedd DP
Metastatic patterns in squamous cell cancer of the head and neck. Am J Surg. 1987 Oct;154(4):439-42.

Phase I Study of Bortezomib and Cetuximab Without or With Cisplatin in Combination With Radiation Therapy for Advanced Head and Neck Cancer

Clinical trial NCT01445405 - References