check_circleStudy Completed

Neoplasms

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

Both

Age

18 - N/A

Trial summary

Enrollment Goal
54
Trial Dates
April 2016 - August 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 groups
    date_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_encryption
    Safety Issue:
    Yes
  • 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 1
    date_rangeTime Frame:
    From pre-dose until 504 hours post dose during cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) for ADC, TA, DM4 and DM4-Me after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1
    date_rangeTime Frame:
    From pre-dose until 504 hours post dose during cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Cmax for ADC, TA, DM4 and DM4-Me after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1
    date_rangeTime Frame:
    From pre-dose until 504 hours post dose during cycle 1
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cmax,md for ADC, TA, DM4 and DM4-Me in Cycle 3
    date_rangeTime Frame:
    From pre-dose until 504 hours post dose during cycle 3
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)md for ADC, TA, DM4 and DM4-Me in Cycle 3
    date_rangeTime Frame:
    From pre-dose until 504 hours post dose during cycle 3
    enhanced_encryption
    Safety Issue:
    No
  • 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 drug
    enhanced_encryption
    Safety Issue:
    No
  • 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 drug
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open label Phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with mesothelin-expressing advanced solid cancers and different stages of concurrent hepatic or renal impairment
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4