check_circleStudy Completed

Medical Oncology

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

Both

Age

18 - N/A

Trial summary

Enrollment Goal
36
Trial Dates
February 2016 - October 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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Withdrawn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Withdrawn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Withdrawn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Withdrawn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 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Plasma concentrations of anetumab ravtansine (BAY 94-9343), pemetrexed and cisplatin
    C (treatment cycle), D (day); Each cycle is defined as a period of 21 days
    date_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, D3
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response evaluation following mRECIST criteria to determine the number of patients with CR, PR, SD or PD
    CR (complete response); PR (partial response); SD (stable disease); PD (progressive disease); Each cycle is defined as a period of 21 days
    date_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 first
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with a positive titer of anti-drug antibodies
    Each cycle is defined as a period of 21 days
    date_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 first
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open label Phase Ib dose escalation study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and maximum tolerated dose of anetumab ravtansine 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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1