DACOGEN Phase II Trials

DACOGEN^® (decitabine) for Injection demonstrated consistent response rates in phase II trials.

• Two open-label, single-arm, phase II trials assessed response rates and safety.¹
• DACOGEN was intravenously infused at a dose of 15 mg/m² over a 4-hour period, every 8 hours, on days 1, 2 and 3 of week 1 every 6 weeks (1 cycle).¹
• Response rates were similar to those seen in the phase III trial¹

Response rates are summarized in Figure 1.

Figure 1. Overall Improvement Rates with DACOGEN^1,3

*CR = complete response; PR = partial response; HI = hematologic improvement.

Platelet Response

In Phase II trials, overall platelet response was 49%, with no significant difference between FAB and IPSS subgroups. Of 126 patients reported as thrombocytopenic at the start of therapy, 54% showed a rise in platelet count, most (58%) of which occurred after only 1 cycle of DACOGEN. Furthermore, an increase in platelet count after 1 cycle of DACOGEN was highly predictive of survival duration (p<0.0001).⁸

Read about the DACOGEN Phase III trial or watch the DACOGEN Clinical Trials Video.

References

IMPORTANT SAFETY INFORMATION

DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using DACOGEN. Men should be advised not to father a child while receiving treatment with DACOGEN, and for 2 months afterwards. The most commonly occurring adverse reactions include neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

DACOGEN is available by prescription only. Please see the important product information for DACOGEN for more information. This site does not contain everything that is known about DACOGEN. If you would like to know more, talk to your healthcare professional.

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