Study to test the safety and efficacy of PF-04449913 with azacitidine versus placebo with azacitidine in patients with Intermediate-2 or high risk myelodysplastic syndrome, acute myeloid leukemia with...

Update Il y a 5 ans
Reference: EUCTR2014-001345-24

Study to test the safety and efficacy of PF-04449913 with azacitidine versus placebo with azacitidine in patients with Intermediate-2 or high risk myelodysplastic syndrome, acute myeloid leukemia with 20-30% blasts and multi-lineage dysplasia, or chronic myelomonocytic

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Extract

Primary Objectives for the Phase 1b (Safety Lead-In) •To assess the safety and tolerability of PF 04449913 when administered in combination with azacitidine in patients with previously untreated Intermediate-2 or High-Risk MDS, AML with 20%-30% blasts and multi-lineage dysplasia or CMML. Primary Objectives for the Randomized Phase 2 Component •To demonstrate superior response rate (RR) of azacitidine and PF-04449913 versus azacitidine and placebo in the treatment of patients with previously untreated Intermediate-2 or High-Risk MDS, AML with 20-30% blasts and multi-lineage dysplasia and CMML.


Inclusion criteria

  • Intermediate-2, High-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia with 20-30% Blasts and Multi-Lineage Dysplasia, or Chronic Myelomonocytic Leukemia

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