check_circleStudy Completed
Medical Oncology
Bayer Identifier:
18329
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Thorough ECG (electrocardiogram) and drug interaction study with anetumab ravtansine and itraconazole
Trial purpose
Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
63Trial Dates
September 2016 - August 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Anetumab ravtansine (BAY94-9343)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | UCLA-Santa Monica Medical Center | Santa Monica, 90404, United States |
Completed | University Hospitals Cleveland Medical Center | Cleveland, 44106, United States |
Completed | Henry Ford Health System | Detroit, 48202, United States |
Completed | Washington University School of Medicine | St. Louis, 63110, United States |
Completed | Mary Crowley Medical Research Center | Dallas, 75230, United States |
Completed | Epworth HealthCare | Richmond, 3122, Australia |
Completed | Blacktown Cancer & Haematology Centre | Blacktown, 2148, Australia |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid, 28040, Spain |
Completed | Hospital Virgen de la Victoria | Málaga, 29010, Spain |
Completed | Centre Georges Francois Leclerc Dijon | DIJON, 21079, France |
Completed | Hôpital Henri Mondor | CRETEIL, 94010, France |
Completed | Hôpital de la Timone - Marseille | MARSEILLE, 13005, France |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | UZ Gent | GENT, 9000, Belgium |
Withdrawn | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Universitair Medisch Centrum St. Radboud | NIJMEGEN, 6525 GA, Netherlands |
Withdrawn | University College Hospital | London, NW1 2BU, United Kingdom |
Completed | Nederlands Kanker Instituut | AMSTERDAM, 1066 CX, Netherlands |
Completed | VUmc | AMSTERDAM, 1081 HV, Netherlands |
Withdrawn | Ochsner Medical Center - New Orleans | New Orleans, 70121-2429, United States |
Withdrawn | Dartmouth Hitchock Medical Center | Lebanon, 03756, United States |
Withdrawn | Univ.of California-San Diego Moores Cancer Center | La Jolla, 92093-1503, United States |
Primary Outcome
- PR interval durationECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
- QRS interval durationECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
- QT interval durationECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
- Abnormal T/U wavesECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
- Heart rateECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
- Cycle 1+2 AUC (area under the plasma concentration vs. time curve from zero to infinity after single (first) dose) of BAY94-9343 analytesdate_rangeTime Frame:At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 10h, 24h, 48h, 168h, 336h, 480h and 504h after each dose during first 42 days of the studyenhanced_encryptionNoSafety Issue:
- Cycle 1+2 AUC(0-tlast) (AUC from time zero to the last data point > LLOQ [lower limit of quantification]) of BAY94-9343 analytesdate_rangeTime Frame:At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 10h, 24h, 48h, 168h, 336h, 480h and 504h after each dose during first 42 days of the studyenhanced_encryptionNoSafety Issue:
- Cycle 1+2 Cmax (maximum drug concentration in plasma after the first dose administration) of BAY94-9343 analytesdate_rangeTime Frame:At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 10h, 24h, 48h, 168h, 336h, 480h and 504h after each dose during first 42 days of the studyenhanced_encryptionNoSafety Issue:
- QTcF (QT interval, corrected for heart rate according to Fridericia's formula) interval durationECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
- QTcP (QT interval, corrected for heart rate using a population-specific correction) interval durationECG evaluationdate_rangeTime Frame:Up to 2 months per patientenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of serious adverse eventsdate_rangeTime Frame:Up to 6 months per patientenhanced_encryptionYesSafety Issue:
- Incidence of non-serious adverse eventsdate_rangeTime Frame:Up to 6 months per patientenhanced_encryptionYesSafety Issue:
- Incidence of positive anti-drug antibody titerdate_rangeTime Frame:Up to 6 months per patientenhanced_encryptionNoSafety Issue:
- Incidence of neutralizing antibody titersdate_rangeTime Frame:Up to 6 months per patientenhanced_encryptionNoSafety Issue:
- Cycle 3 Cmax,md (Cmax after multiple-dose administration) of BAY94-9343 analytesdate_rangeTime Frame:At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 168h, 336h and 504h between 43rd and 64th days of the studyenhanced_encryptionNoSafety Issue:
- Cycle 3 AUC(0-tlast)md (AUC(0-tlast) after multiple-dose administration) of BAY94-9343 analytesdate_rangeTime Frame:At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 168h, 336h and 504h between 43rd and 64th days of the studyenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1