Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.

PHASE1CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

September 7, 2011

Primary Completion Date

December 31, 2016

Study Completion Date

July 30, 2019

Conditions
Oncology
Interventions
DRUG

BAY94-9343

BAY94-9343 was administered intravenously in this study. The starting dose for this first-in-man study was 0.15 mg/kg administered as a 1 hour infusion every 21 days.

DRUG

BAY94-9343 (Expansion)

BAY94-9343 was administered intravenously in this study. The dose for this expansion cohort was 5.5mg/kg administered as a 1 hour infusion every 21 days.

DRUG

BAY94-9343 (1.8 mg/kg)

BAY94-9343 was administered intravenously in this study. The dose for this cohort was 1.8 mg/kg administered as a 1 hour infusion every week for 3 weeks.

DRUG

BAY94-9343 (2.2 mg/kg)

BAY94-9343 was administered intravenously in this study. The dose for this cohort was 2.2 mg/kg administered as a 1 hour infusion every week for 3 weeks.

Trial Locations (8)

20892

Bethesda

37203

Nashville

48201

Detroit

60637

Chicago

73104

Oklahoma City

75251

Dallas

77030

Houston

06520-8063

New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY