NCT01858181 - 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)

Forero-Torres A, de Vos S, Pohlman BL, Pashkevich M, Cronier DM, Dang NH, Carpenter SP, Allan BW, Nelson JG, Slapak CA, Smith MR, Link BK, Wooldridge JE, Ganjoo KN
Results of a phase 1 study of AME-133v (LY2469298), an Fc-engineered humanized monoclonal anti-CD20 antibody, in Fc?RIIIa-genotyped patients with previously treated follicular lymphoma. Clin Cancer Res. 2012 Mar 1;18(5):1395-403. doi: 10.1158/1078-0432.CCR-11-0850. Epub 2012 Jan 5.
Tobinai K, Ogura M, Kobayashi Y, Uchida T, Watanabe T, Oyama T, Maruyama D, Suzuki T, Mori M, Kasai M, Cronier D, Wooldridge JE, Koshiji M
Phase I study of LY2469298, an Fc-engineered humanized anti-CD20 antibody, in patients with relapsed or refractory follicular lymphoma. Cancer Sci. 2011 Feb;102(2):432-8. doi: 10.1111/j.1349-7006.2010.01809.x. Epub 2011 Jan 12.

A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies

Details for clinical trial NCT01858181

Clinical trial NCT01858181 - References