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TP53 mutations are common in hematological malignancies and confer a dismal prognosis. APR-246 is the first compound targeting mutant p53 to enter into a clinical trial.
In this first in-man study, APR-246 was given daily as a 2h intravenous infusion for 4 consecutive days with a maximum tolerated dose of 60mg/kg daily. This trial was an extension of the first in-man study to determine the dose limiting toxicity (DLT), safety, pharmacokinetic profile, and anti-tumor effects of APR-246. The data was published by S. Deneberg, et al., in Blood Cancer Journal in July 2016. The trial was conducted in accordance to the Declaration of Helsinki and ICH-GCP guidelines and was registered at ClinicalTrial.gov (NCT00900614).
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