check_circleStudy Completed
Medical Oncology
Bayer Identifier:
17631
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase Ib study of anetumab ravtansine in combination with pemetrexed and cisplatin in mesothelin-expressing solid tumors
Trial purpose
Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY 94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell lung cancer.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
36Trial Dates
February 2016 - October 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Anetumab ravtansine (BAY94-9343)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bethesda, 20892, United States | |
Completed | Chicago, 60637, United States | |
Withdrawn | Houston, 77030, United States | |
Completed | Charleston, 29425, United States | |
Completed | Detroit, 48202, United States | |
Withdrawn | New Orleans, 70121, United States | |
Completed | Milano, 20133, Italy | |
Completed | Milano, 20089, Italy | |
Withdrawn | Parma, 43126, Italy | |
Withdrawn | Siena, 53100, Italy |
Primary Outcome
- Maximum tolerated dose (MTD)MTD is defined as the highest dose of oral anetumab ravtansine (BAY 94-9343) administered in combination with IV pemetrexed and cisplatin that can be given such that not more than 1 of 6 subjects at a given dose level experience a DLT (dose-limiting toxicity).date_rangeTime Frame:Up to 2 yearsenhanced_encryptionYesSafety Issue:
- Number of subjects with adverse events and serious adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 2 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Plasma concentrations of anetumab ravtansine (BAY 94-9343), pemetrexed and cisplatinC (treatment cycle), D (day); Each cycle is defined as a period of 21 daysdate_rangeTime Frame:- BAY 94-9343: C1D1,D2,D3,D8,D15, C2D1, C3D1,D2,D3,D8,D15, C4D1, C6D1 and subsequent cycles every 3rd cycle up to 2 years or until discontinuation of study treatment, whichever comes first - Pemetrexed: C1D1, D2, D3 - Cisplatin: C1D1, D2, D3enhanced_encryptionNoSafety Issue:
- Tumor response evaluation following mRECIST criteria to determine the number of patients with CR, PR, SD or PDCR (complete response); PR (partial response); SD (stable disease); PD (progressive disease); Each cycle is defined as a period of 21 daysdate_rangeTime Frame:Baseline, every 8 weeks up to cycle 12; then every 12 weeks from cycle 13 up to 2 years, or until discontinuation of study treatment, whichever comes firstenhanced_encryptionNoSafety Issue:
- Number of patients with a positive titer of anti-drug antibodiesEach cycle is defined as a period of 21 daysdate_rangeTime Frame:Day1 of C1, C3, C6 and subsequent cycles every 3rd cycle up to 2 years or until discontinuation of study treatment, whichever comes firstenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1