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drugset / Trial / NCT00957580

Trial of Pimasertib in Hematological Malignancies

NCT00957580 ↗

Phase 2 Terminated 81 enrolled EMD Serono
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts: Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies. Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.

Timeline

Start
2009-09-30
Primary completion
2012-12-31
Completion
2012-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimasertib Small molecule 8 mg Oral
Subject Pimasertib Small molecule 15 mg Oral
Subject Pimasertib Small molecule 23 mg Oral
Subject Pimasertib Small molecule 30 mg Oral
Subject Pimasertib Small molecule 42 mg Oral
Subject Pimasertib Small molecule 45 mg Oral
Subject Pimasertib Small molecule 60 mg Oral
Subject Pimasertib Small molecule 75 mg Oral
Subject Pimasertib Small molecule 90 mg Oral

Indications

acute myeloid leukemia