check_circleStudy Completed
Oncology
Bayer Identifier:
15051
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase I study to determine the maximum tolerable dose of BAY94-9343 in patients with advanced solid tumors.
Trial purpose
BAY94-9343 was an antibody-drug conjugate (ADC) directed against the cancer antigen mesothelin on tumor cells.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
148Trial Dates
September 2011 - July 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Anetumab ravtansine (BAY94-9343)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Nashville, 37203, United States | |
Completed | Houston, 77030, United States | |
Completed | Bethesda, 20892, United States | |
Completed | Oklahoma City, 73104, United States | |
Completed | Detroit, 48201, United States | |
Completed | New Haven, 06520-8063, United States | |
Completed | Chicago, 60637, United States | |
Completed | Dallas, 75251, United States | |
Withdrawn | Minneapolis, 55455, United States |
Primary Outcome
- Incidence of DLT (dose limiting toxicity) of BAY 94-9343date_rangeTime Frame:At the end of Cycle 1 Day21enhanced_encryptionYesSafety Issue:
- Determination of the Pharmacokinetic profile of BAY94-9343 and its metabolites (ADC, Total Antibody, DM4 and DM4-Me)Q3W Arm: Cmax, AUC (0-504), AUC (0-tlast), tmax, t1/2 and AUC (Cycle 1 only) Q3W: Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, (24), 48, (96), 168, 336 and 504 hours after start of infusion QW Arm:Cmax, AUC(0-168) and tmax) QW: Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48 and 168 hours after start of infusiondate_rangeTime Frame:Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, (24), 48, (96), 168, 336 and 504 hours after start of infusionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Biomarker evaluation: Plasma concentrations of soluble mesothelin and Cytokeratin 18 (CK18)date_rangeTime Frame:C1D1: pre-dose, 24, 48, and 168h after start of infusion; C2D1: pre-dose, 4 and 168h after start of infusion; C3D1: pre-dose, 24, 48, and 168h after start of infusion; C4 and every even cycle: pre-dose until Implementation of Am 6enhanced_encryptionNoSafety Issue:
- Tumor response: assessment of best response and PFS (progression free survival) according to RECIST (Response Evaluation Criteria in Solid Tumours) 1.1date_rangeTime Frame:1 year/Screening; Within 5 days before the end of every even cycle until Cycle 8 (Cycle 2, Cycle 4, etc.); Within 5 days before the end of every 4th cycle after Cycle 8 (Cycle 12, 16, etc.); end of treatmentenhanced_encryptionNoSafety Issue:
- Immunogenicity assessment: assessment of Anti-drug antibody (ADA) formation and neutralizing antibodies (NAs) against anetumab ravtansinedate_rangeTime Frame:1 year / Cycle 1, 2 and 3 Day 1: pre-dose; Day 1 of every even cycle starting from Cycle 4 (Cycle 4, 6, 8 etc.): pre-dose until implementation of Am 6enhanced_encryptionNoSafety Issue:
- Biomarker evaluation - Levels of mesothelin expression in tumor tissuedate_rangeTime Frame:Anytime prior to general screeningenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
4