check_circleStudy Completed

Medical oncology

Bayer Identifier:

17616

ClinicalTrials.gov Identifier:

NCT02457351

EudraCT Number:

Not Available

EU CT Number:

Not Available
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.

  • 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
July 2015 - April 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Edmonton, T6G 1Z2, Canada
Completed
Hamilton, L8V 5C2, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
London, N6A 4L6, Canada

Primary Outcome

  • Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole)
    date_rangeTime Frame:
    Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole)
    date_rangeTime Frame:
    Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole)
    date_rangeTime Frame:
    Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole)
    date_rangeTime Frame:
    Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole
    date_rangeTime Frame:
    up to 15 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
    Complete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy test
    date_rangeTime Frame:
    up to 15 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
    date_rangeTime Frame:
    up to 15 months
    enhanced_encryption
    Safety Issue:
    Yes
  • East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
    date_rangeTime Frame:
    up to 15 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
    date_rangeTime Frame:
    up to 15 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
    date_rangeTime Frame:
    up to 15 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)
    date_rangeTime Frame:
    Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration vs. time curve from zero to 24 hr (AUC) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)
    date_rangeTime Frame:
    Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label, non-randomized, Phase I study to evaluate the effect of itraconazole on the pharmacokinetics of a single oral dose of roniciclib in patients with advanced solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.