The aim of the phase 1 portion of the trial is to find out whether PCM-075 given orally daily for 5 consecutive days every 28 days is safe and tolerable in such patients or in those AML patients who are ineligible for intensive induction therapy. The researchers are also trying to determine the maximum tolerated dose of PCM-075 or recommended phase 2 dose of PCM-075 in combination with decitabine and/or PCM-075 in combination with low-dose cytarabine.
The primary outcomes of the phase 1 portion of the trial are the number of participants with dose-limiting toxicity and adverse events from baseline out to 30 days after the last dose of PCM-075, up to 27 months. The primary outcome of phase 2 , called, will be the rate of complete response plus complete response with incomplete blood count recovery out to 27 months.
The PLK1 enzyme is overexpressed in multiple hematologic and solid tumor cancers, and studies have shown that inhibition of polo-like kinases can lead to tumor cell death, Trovagene said in its.
Bill Welch, CEO of Trovagene, added that “PCM-075 is the first highly PLK1-selective competitive inhibitor administered orally to enter clinical trials with potential activity in both hematologic and solid tumor cancers.”