check_circleStudy Completed
Neoplasms
Bayer Identifier:
12876
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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?
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?
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
64Trial Dates
July 2011 - April 2014Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinik für Tumorbiologie Freiburg | Freiburg, 79106, Germany |
Completed | Erasmus Medisch Centrum | ROTTERDAM, 3015 CE, Netherlands |
Active, not recruiting | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | Shea Medical Center | Scottsdale, 85260, United States |
Completed | Tyler Cancer Center | Tyler, 75702, United States |
Completed | Northwest Cancer Specialists, PC | Vancouver, 98684, United States |
Completed | Comprehensive Cancer Centers of Nevada | Las Vegas, 89169, United States |
Completed | Greenville Health System | Greenville, 29605, United States |
Primary Outcome
- Maximum Tolerated Dosedate_rangeTime Frame:2 yearsenhanced_encryptionYesSafety Issue:
- Comparison of the Copanlisib AUC when given alone with the AUC when given with Refametinib (BAY86-9766)date_rangeTime Frame:At day 15enhanced_encryptionNoSafety Issue:
- Comparison of the Refametinib (BAY86-9766) AUC when given alone with the AUC when given with Copanlisibdate_rangeTime Frame:At day 15enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Tumor Response as measured by RECIST 1.1 criteriadate_rangeTime Frame:3 yearsenhanced_encryptionNoSafety Issue:
- Biomarker evaluation including analysis of pathway activation in blood and plasmadate_rangeTime Frame:3 yearsenhanced_encryptionNoSafety Issue:
- Tumor Response as measured by FDG-PET at MTD and expansion cohort(s)date_rangeTime Frame:3 yearsenhanced_encryptionNoSafety Issue:
- Pharmacodynamic biomarker evaluation analysis using paired tumor biopsiesdate_rangeTime Frame:3 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1