PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) — LAM-PIK  

Acute Myeloid Leukemia, in Relapse Clinical Trial

Official title: Phase II Evaluating the Efficacy of the Dual Inhibition of Phosphoinositide 3 Kinase (PI3K)/Akt /Mammalian Target Of Rapamycine (mTOR) Signaling Pathway by PF-05212384 (PKI-587) for Patients With Myeloid Neoplasm Secondary to Chemo-radiotherapy (t-AML/MDS) or de Novo Relapsed or Refractory AML.

Status Terminated

Clinical Trial Summary

Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.

Clinical Trial Description

The treatment is administered in cycles of 28 days for a period of 4 cycles. Patients will be treated on a weekly basis continuously during 112 days or until progression.

Blood tests (hemogram) are assessed weekly before each injection of PF-05212384 (PKI-587). Bone marrow aspiration (myelogram) is performed to evaluate the response before starting treatment and before the start of cycle 3 (after two cycles) and at the end of the study (after four cycles). Good responders who continue treatment after four cycles will be evaluated by bone marrow aspiration (myelogram) every two cycles and after the end of treatment ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, in Relapse
• de Novo Acute Myeloid Leukemia at Diagnostic
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome

• NCT number: NCT02438761
• Study type: Interventional
• Source: Institut Curie
• Status: Terminated
• Phase: Phase 2
• Start date: August 31, 2015
• Completion date: April 23, 2018