Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age greater than/equal to 18 years old
ECOG Performance Status of 0 - 1
Life expectancy of at least 12 weeks
Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy or have no standard therapy available
LVEF (left ventricular ejection fraction) \> or = to the lower limit of normal for the institution
Radiographically or clinically evaluable tumor
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose:
* Hemoglobin \> 9.0 g/dL
* Absolute neutrophil count (ANC) \> or = 1500/mm3
* Platelet count \> or = 100,000 /mm3
* Total bilirubin \< or = 1.5 times the upper limit of normal
* ALT (alanine aminotransferase) and AST (aspartate aminotransferase) \< or = 2.5 x upper limit of normal (\< or = 5 x upper limit of normal for patients with liver involvement)
* PT-INR (prothrombin-international normalized ratio) and PTT (partial thromboplastin time) \< or = 1.5 times the upper limit of normal
* Serum creatinine \< or = 1.5 times the upper limit of normal
You may not be if
History of impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) NYHA (New York Heart Association) Class III or IV); active coronary artery disease, myocardial infarction within 6 months of study entry; new onset or unstable angina within 3 months of study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy
Type 1 or type 2 diabetes mellitus or fasting glucose \> 125 mg/dL or HgBA1c \> or = 7.0
Use of systemic corticosteroids within 2 weeks of study entry
History of retinal vein occlusion
Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Active clinically serious infection
Uncontrolled hypertension
Positive for HIV, or chronic Hepatitis B or C
Subjects undergoing renal dialysis
Known bleeding diathesis
Ongoing substance abuse
Pregnant or breast-feeding women
Clareo Health | Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer
