drugset / Trial / NCT00687323

Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052)

NCT00687323 ↗

Phase 2 Completed 47 enrolled Merck Sharp & Dohme LLC
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety, tolerability, and efficacy of temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants who are not candidates for standard induction therapy and exhibit low MGMT expression.

Timeline

Start
2007-07-30
Primary completion
2011-05-09
Completion
2012-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 100 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral