NCT01273194 - 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)

Gatta G, Capocaccia R, Coleman MP, Ries LA, Berrino F
Childhood cancer survival in Europe and the United States. Cancer. 2002 Oct 15;95(8):1767-72.
Harris MB
Palliative care in children with cancer: which child and when? J Natl Cancer Inst Monogr. 2004;(32):144-9. Review.
Wolfe J, Grier HE, Klar N, Levin SB, Ellenbogen JM, Salem-Schatz S, Emanuel EJ, Weeks JC
Symptoms and suffering at the end of life in children with cancer. N Engl J Med. 2000 Feb 3;342(5):326-33.

Evaluating Supportive Care for Children With Cancer: A Multi-Institutional Survey Study of Pediatric Oncology Patients and Parents

Clinical trial NCT01273194 - References