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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01392521
First Posted: July 12, 2011
Last Update Posted: April 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
June 30, 2011
July 12, 2011
April 17, 2015
July 2011
February 2014   (Final data collection date for primary outcome measure)
  • Maximum Tolerated Dose [ Time Frame: 2 years ]
  • Comparison of the Copanlisib AUC when given alone with the AUC when given with Refametinib (BAY86-9766) [ Time Frame: At day 15 ]
  • Comparison of the Refametinib (BAY86-9766) AUC when given alone with the AUC when given with Copanlisib [ Time Frame: At day 15 ]
  • Maximum Tolerated Dose [ Time Frame: 2 years ]
  • Comparison of the BAY80-6946 AUC when given alone with the AUC when given with BAY86-9766 [ Time Frame: At day 15 ]
  • Comparison of the BAY86-9766 AUC when given alone with the AUC when given with BAY80-6946 [ Time Frame: At day 15 ]
Complete list of historical versions of study NCT01392521 on ClinicalTrials.gov Archive Site
  • Tumor Response as measured by RECIST 1.1 criteria [ Time Frame: 3 years ]
  • Biomarker evaluation including analysis of pathway activation in blood and plasma [ Time Frame: 3 years ]
  • Tumor Response as measured by FDG-PET at MTD and expansion cohort(s) [ Time Frame: 3 years ]
  • Pharmacodynamic biomarker evaluation analysis using paired tumor biopsies [ Time Frame: 3 years ]
  • Tumor Response as measured by RECIST 1.1 criteria [ Time Frame: 2 years ]
  • Biomarker evaluation including analysis of pathway activation in tumor tissue and blood/plasma [ Time Frame: 2 years ]
Not Provided
Not Provided
 
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
Phase Ib Trial of the Combination of PI3K Inhibitor BAY 80-6946 and Allosteric-MEK Inhibitor BAY 86-9766 in Subjects With Advanced Cancer

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?
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
  • Drug: Copanlisib + Refametinib (BAY86-9766)
    Copanlisib will be administered as an IV infusion weekly for 3 weeks in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 4 of Cycle 1.
  • Drug: Copanlisib + Refametinib (BAY86-9766)
    Copanlisib will be administered as an IV infusion weekly in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 6 of Cycle 1 on a 4 day on, 3 day off schedule.
Experimental: Arm 1
Interventions:
  • Drug: Copanlisib + Refametinib (BAY86-9766)
  • Drug: Copanlisib + Refametinib (BAY86-9766)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   United States
 
 
NCT01392521
12876
2010-024082-45 ( EudraCT Number )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP