check_circleStudy Completed
Neoplasms
Bayer Identifier:
18327
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase I study of anetumab ravtansine in hepatic or renal impairment
Trial purpose
To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or renal impairment
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
54Trial Dates
April 2016 - August 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Anetumab ravtansine (BAY94-9343)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | TOULOUSE CEDEX 9, 31059, France | |
Completed | LILLE CEDEX, 59020, France | |
Completed | Chisinau, 2025, Moldova | |
Completed | MARSEILLE CEDEX 5, 13385, France | |
Completed | SAINT HERBLAIN, 44805, France | |
Completed | DIJON, 21079, France | |
Completed | LYON CEDEX, 69008, France | |
Completed | CAEN, 14073, France |
Primary Outcome
- Number of subjects with treatment-emergent adverse events (TEAEs) and significant abnormalities in safety assessments related to anetumab ravtansine (BAY94-9343) in each of the 4 treatment groupsdate_rangeTime Frame:After the first application of the study drug up until the safety follow up visit, i.e., 30-35 days after the last dose of the study drug.enhanced_encryptionYesSafety Issue:
- AUC for antibody drug conjugate (ADC), total antibody (TA), derivative 4 of maytansine (DM4), and S methyl derivate of DM4 (DM4-Me) after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1date_rangeTime Frame:From pre-dose until 504 hours post dose during cycle 1enhanced_encryptionNoSafety Issue:
- AUC(0-tlast) for ADC, TA, DM4 and DM4-Me after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1date_rangeTime Frame:From pre-dose until 504 hours post dose during cycle 1enhanced_encryptionNoSafety Issue:
- Cmax for ADC, TA, DM4 and DM4-Me after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1date_rangeTime Frame:From pre-dose until 504 hours post dose during cycle 1enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Cmax,md for ADC, TA, DM4 and DM4-Me in Cycle 3date_rangeTime Frame:From pre-dose until 504 hours post dose during cycle 3enhanced_encryptionNoSafety Issue:
- AUC(0-tlast)md for ADC, TA, DM4 and DM4-Me in Cycle 3date_rangeTime Frame:From pre-dose until 504 hours post dose during cycle 3enhanced_encryptionNoSafety Issue:
- Number of subjects with positive immunogenicity results for anti anetumab ravtansine (BAY94-9343) antibodies (anti drug antibody [ADA])date_rangeTime Frame:From pre-dose on Day1 of Cycle 1 until the safety follow-up visit, i.e., 30-35 days after the last dose of the study drugenhanced_encryptionNoSafety Issue:
- Number of subjects with positive immunogenicity results for anetumab ravtansine (BAY94-9343) neutralizing antibody (NAB)date_rangeTime Frame:From pre-dose on Day1 of Cycle 1 until the safety follow-up visit, i.e., 30-35 days after the last dose of the study drugenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
4