Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Assistance Publique - Hôpitaux de Paris
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age \> 18 years
Stage IV or un-resectable stage III melanoma
Presence of BRAF V600E/K mutation and CDNKN2A loss and expression of Rb using immunohistochemistry in a recent metastatic sample (\< 6 months)
A previous exposure to BRAF inhibitor or combination of BRAF and MEK inhibitors therapy is allowed unless it has been stopped more than 3 months before study enrolment(This will defined the two strata of the trial)
No previous therapy by MEK inhibitor unless associated with BRAF inhibitors
No previous therapy with the AKT/PI3K pathway inhibitor
Patients should have a tumour available for repeated biopsies for pharmacodynamics evaluation
Life expectancy of \> 3 months
ECOG performance status \<2
Signed informed consent
Patient with health insurance coverage
No patient under guardianship or curators
Myocardial infarct or unstable angina within the past 6 months
Concomitant take of drugs known to be strong inhibitor or inducers of CYP314
HIV positive.
Chemotherapy, immunotherapy within 4 weeks
Drugs interfering with PD-0332991 and vemurafenib metabolism
Malabsorption syndrome or other condition that would interfere with enteral absorption
Congenital long QT syndrome or screening QTc \> 470 msec
Need for chronic corticosteroid therapy of ≥10 mg of prednisone per day
You may not be if
Inadequate hepatic function defined as serum bilirubin\>25 μmol/l, transaminases \> 3.0 times the upper limit of normal (ULN) or 5ULN in cases of liver metastases;
Inadequate bone marrow function defined as absolute neutrophil count\<1500/mcl, platelets\<150000/mcl and haemoglobin\<8g/dL
Inadequate renal function with serum creatinine\>2.0mg/dl) and /or creatinine clearance\< 60 ml/min
Clareo Health | Phase I-II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation and Pharmacokinetics of PD-0332991 in Patients Suffering Metastatic Melanoma
