NCT01222780 - 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)

Chonn A, Cullis PR
Recent advances in liposomal drug-delivery systems. Curr Opin Biotechnol. 1995 Dec;6(6):698-708. Review.
Linabery AM, Ross JA
Trends in childhood cancer incidence in the U.S. (1992-2004). Cancer. 2008 Jan 15;112(2):416-32.
Ross JA, Olshan AF
Pediatric cancer in the United States: the Children's Oncology Group Epidemiology Research Program. Cancer Epidemiol Biomarkers Prev. 2004 Oct;13(10):1552-4.

Phase I Trial to Evaluate the Safety, Activity and Pharmacokinetics of Marqibo(Registered Trademark) (Vincristine Sulfate Liposomes Injection) in Children and Adolescents With Refractory Cancer

Details for clinical trial NCT01222780

Clinical trial NCT01222780 - References