Trial Condition(s):

Neoplasms

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

Bayer Identifier:

12876

ClinicalTrials.gov Identifier:

NCT01392521

EudraCT Number:

2010-024082-45

Study Completed

Trial Purpose

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?

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
64
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Klinik für Tumorbiologie Freiburg

Freiburg, Germany, 79106

Status
Completed
 
Locations

Erasmus Medisch Centrum

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Active, not recruiting
 
Locations

Shea Medical Center

Scottsdale, United States, 85260

Status
Completed
 
Locations

Tyler Cancer Center

Tyler, United States, 75702

Status
Completed
 
Locations

Northwest Cancer Specialists, PC

Vancouver, United States, 98684

Status
Completed
 
Locations

Comprehensive Cancer Centers of Nevada

Las Vegas, United States, 89169

Status
Completed
 
Locations

Greenville Health System

Greenville, United States, 29605

Status
Completed
 

Trial Design