Trial Condition(s):
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
12876
Not Available
The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions:
1. What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels?
2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies?
3. How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect?
4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect?
5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors?
- 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
- 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
Locations | |
---|---|
Locations Klinik für Tumorbiologie Freiburg Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3015 CE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shea Medical Center Scottsdale, United States, 85260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tyler Cancer Center Tyler, United States, 75702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwest Cancer Specialists, PC Vancouver, United States, 98684 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive Cancer Centers of Nevada Las Vegas, United States, 89169 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Greenville Health System Greenville, United States, 29605 | Contact Us: E-mail: [email protected] Phone: Not Available |
Phase Ib trial of the combination of PI3K inhibitor BAY 80-6946 and allosteric-MEK inhibitor BAY 86-9766 in subjects with advanced cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1