Trial Condition(s):

Medical Oncology

COPANLISIB (BAY80-6946) drug-drug interaction and cardiovascular safety study in advanced solid tumor and non-Hodgkin's lymphoma patients

Bayer Identifier:

16270

ClinicalTrials.gov Identifier:

NCT02253420

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To evaluate the effect of itraconazole or rifampin on the absorption, distribution, metabolism and elimination of COPANLISIB (BAY80-6946).

To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.

Inclusion Criteria
-  Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors or non-Hodgkin's lymphoma that have progressed on, or failed to respond to, therapies known to provide clinical benefit may be enrolled after signing informed consent.
 -  Normal left ventricular ejection fraction; adequate liver, renal and bone-marrow functions as assessed by laboratory values.
 -  Adequate performance status and life expectancy of at least 3 months.
Exclusion Criteria
-  Solid-tumor patients with central nervous system (CNS) metastases if treatment completed < 3 months before enrollment or lesions unstable or progressing on MRI scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases.
 -  Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF greater than NYHA Class II
 -  Active coronary artery disease or myocardial infarction within the 6 months before study entry; any new-onset angina within the 3 months before study entry or unstable angina; cardiac arrhythmia requiring anti-arrhythmic therapy.
 -  Prior diagnosis of Type 1 or 2 diabetes mellitus, hyperglycemia (defined as fasting blood or plasma glucose above 125 mg/dL under 2 separate days, corresponding to 6.94 mmol/L) or HbA1c ≥ 7%.
 -  Use of systemic including inhaled corticosteroids within the 2 days before the start of study treatment (however, topical steroids are permitted).
 -  Known presence of human immunodeficiency virus (HIV) infection or active hepatitis (B or C).
 -  Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical management).
 -  Anticancer chemotherapy, hormone therapy or immunotherapy within the 4 weeks before the first study treatment or scheduled for administration (of the above) during the study
 -  History of, or concurrent, interstitial lung disease (ILD) or severely impaired pulmonary function.
 -  Medications with drug-drug interaction potential for itraconazole which is to be excluded before the study and during Cycle 1 such as CYP3A4 substrates with a narrow therapeutic window or which have the potential to prolong QTc 
- Concomitant medication contraindicated for use with rifampin (including, but not limited to): cisapride, oral midazolam, nisoldipine, pimozide, quinidine, dofetilide, triazolam, levacetylmethadol (levomethadyl), 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA)-reductase inhibitors metabolised by CYP3A4, such as lovastatin and simvastatin, ergot alkaloids metabolised by CYP3A4, such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), atazanavir, darunavir, fosamprenavir, ritonavir-boosted saquinavir, saquinavir, or tipranavir

Trial Summary

Enrollment Goal
51
Trial Dates
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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

Investigative Site

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

Investigative Site

Vancouver, Canada, V5Z 4E6

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Investigative Site

Dallas, United States, 75230

Status
Completed
 

Trial Design