check_circleStudy Completed
Medical Oncology
Bayer Identifier:
16270
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
COPANLISIB (BAY80-6946) drug-drug interaction and cardiovascular safety study in advanced solid tumor and non-Hodgkin's lymphoma patients
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.
To evaluate the effect of copanlisib on QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular safety.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
51Trial Dates
October 2014 - August 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hamilton, L8V 5C2, Canada | |
Completed | Vancouver, V5Z 4E6, Canada | |
Completed | Edmonton, T6G 1Z2, Canada | |
Completed | Toronto, M5G 2M9, Canada | |
Completed | Dallas, 75230, United States |
Primary Outcome
- AUC (0–168)AUC (0–168): Area under the curve from dosing to 168 h after dosingdate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- AUCAUC: Area under the curvedate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- CmaxCmax: Maximum concentration attained after dosingdate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- QTcFQTcF: Time-matched largest change of QT interval (Frederica’s correction)date_rangeTime Frame:Holter Monitoring performed on Cycle 1 Day -1 (baseline) and Cycle 1 Day 1 (each cycle is 28 days)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- AUC(0–tlast)AUC(0–tlast): Area under the curve from dosing to last measurable concentrationdate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- tmaxtmax: Time from dosing to attainment of Cmaxdate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- tlasttlast: Time from dosing to last measurable concentrationdate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- t1/2t1/2: Terminal half-lifedate_rangeTime Frame:Within cycle 1, at pre-dose and at 10 min, 1, 1.33 (arm B)1.5 (arm A), 2, 2.5, 3, 5, 8, 24, 48, 72, 96, 120, and 168 hours after start of drug infusion on Days 1 and 15.enhanced_encryptionNoSafety Issue:
- Urine [AE,ur(0–24)]Amount of drug excreted via urine during the collection interval 0 - 24 hours post administrationdate_rangeTime Frame:From 0–8 hours and >8 up to 24 hours after the start of copanlisib infusion on Days 1 and 15 of Cycle 1enhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerabilitySafety analysis will be conducted continuously until safety follow-update_rangeTime Frame:At approximately 29 monthsenhanced_encryptionYesSafety Issue:
- PR intervalsdate_rangeTime Frame:Holter Monitoring performed on Cycle 1 Day -1 (baseline) and Cycle 1 Day 1 (each cycle is 28 days)enhanced_encryptionYesSafety Issue:
- QRS intervalsdate_rangeTime Frame:Holter Monitoring performed on Cycle 1 Day -1 (baseline) and Cycle 1 Day 1 (each cycle is 28 days)enhanced_encryptionYesSafety Issue:
- ECG waveform morphologydate_rangeTime Frame:Holter Monitoring performed on Cycle 1 Day -1 (baseline) and Cycle 1 Day 1 (each cycle is 28 days)enhanced_encryptionYesSafety Issue:
- Left ventricular ejection fraction (LVEF)MUGA scansdate_rangeTime Frame:At baseline, in the last week of Cycle 1, and in the last 2 weeks of Cycle 2, Cycle 3, Cycle 6 and every third cycle (Cycle 9, Cycle 12, etc.) and end of treatmentenhanced_encryptionYesSafety Issue:
- QTcBQTcB: Bazett’s corrected QT intervaldate_rangeTime Frame:Holter Monitoring performed on Cycle 1 Day -1 (baseline) and Cycle 1 Day 1 (each cycle is 28 days)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
2