Trial Condition(s):

Medical Oncology

Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

Bayer Identifier:

17616

ClinicalTrials.gov Identifier:

NCT02457351

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients.
To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients

Inclusion Criteria
-  Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
 -  Adequate liver, renal and bone-marrow functions as assessed by laboratory values.
 -  ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks.   
 -  Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug.
Exclusion Criteria
Medical and surgical history:
 -  Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism. 
 -  History of cardiac disease:  congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
 -  Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management)
 -  Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
 -  Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) > Grade 2.
 -  Symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. 
 -  Seizure disorder requiring therapy (such as steroids or anti-epileptics).
 -  History of organ allograft.
 -  Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment

Trial Summary

Enrollment Goal
14
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Investigative Site

London, Canada, N6A 4L6

Status
Completed
 

Trial Design