Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 3, 2016

Primary Completion Date

May 23, 2018

Study Completion Date

October 17, 2019

Conditions
Medical Oncology
Interventions
DRUG

BAY 94-9343

"In Part 1 of the study, anetumab ravtansine (BAY 94-9343) will be administered by 1-hour IV infusion with a starting dose of 5.5mg/kg(BW) on Day 1 of every treatment cycle (Q3W).~In Part 2 of the study, anetumab ravtansine (BAY 94-9343) will be administered on Day 2 of Cycle 1 and then on Day 1 of Cycle 2 and all subsequent cycles (Q3W)"

DRUG

Pemetrexed

Administered at the dose of 500 mg/m2 body surface area (BSA) by 10-minute IV infusion on Day 1 of every treatment cycle (Q3W) in both parts of the study

DRUG

Cisplatin

Administered at the dose of 75 mg/m2 (BSA) by 2-hour IV infusion on Day 1 of every treatment cycle (Q3W) in both parts of the study

Trial Locations (6)

20089

Milan

20133

Milan

20892

Bethesda

29425

Charleston

48202

Detroit

60637

Chicago

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY