PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML… (NCT02438761) | Clinical Trial Compass
TerminatedPhase 2
PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (LAM-PIK)
Stopped: No objective response was observed at the first step. The treatment was considered ineffective, with a complete clinical trial suspension.
France10 participantsStarted 2015-08-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients belong to one of three categories:
✓. Adequate glycemic balance defined by glycated hemoglobin ≤ 8%
✓. Females of childbearing potential (FCBP) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
✓. Absence of severe or active infection
✓. Adequate systolic cardiac function : Left Ventricular Ejection Fraction (LVEF) ≥ 50%
✓. Adequate hepatic function: Aspartate Aminotransferase Test (AST) and Alanine Aminotransferase Test (ALT) ≤ 3 times the upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN
✓. Adequate renal function: serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance \> 60 ml/min.
Exclusion criteria
✕. Glucose intolerance or diabetes mellitus, treated or untreated
✕. First cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
✕. AML secondary to MDS or myeloproliferative syndrome (WHO 2008 definitions)
✕. Acute Promyelocytic Leukaemia (APL or AML French American British (FAB) classification 3) de novo or secondary to treatment (t-APL)
✕. de novo or secondary Core Binding Factor (CBF)/AML
✕. de novo or secondary Philadelphia Chromosome (Ph) 1 positive AML defined by the presence of a t(9.22) or a Breakpoint Cluster Region-Abelson Murine Leukemia Viral Oncogene Homolog (BCR-ABL) transcript
✕. Leukocytes above 30.000/mm3 (30 G/L) at enrollment
✕. Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea