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
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
14
Part 1 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 mg Cycle 1 Day 6: Single dose 2.5 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 or 5 mg (based on Part 1 data) Cycle 1 Day 6: Single dose 2.5 or 5 mg (based on part 1 data) Part 1 \& Part 2 Cycle 2 and subsequent 21-day cycles: Day 1-3 of each cycle: 5 mg bid Day 4-7 of each cycle: no dose
Part 1 \& Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd
Unnamed facility
Edmonton, Alberta, Canada
Unnamed facility
Hamilton, Ontario, Canada
Unnamed facility
London, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole)
Time frame: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing
Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole)
Time frame: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing
Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole)
Time frame: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing
Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole)
Time frame: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing
Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole
Time frame: up to 15 months
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
Time frame: up to 15 months
Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
Time frame: up to 15 months
East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 15 months
Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
Time frame: up to 15 months
Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole
Time frame: up to 15 months
Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)
Time frame: Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing
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)
Time frame: Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing