Recruitment

Recruitment Status
Completed
Estimated Enrollment
42

Inclusion Criterias

Adequate bone marrow, liver, and renal function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
Adequate bone marrow, liver, and renal function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard

Exclusion Criterias

Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
History of severe allergic reactions to monoclonal antibody therapy
Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
History of severe allergic reactions to monoclonal antibody therapy
Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management

Summary

Conditions
Neoplasms
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 125 years
Gender
Both males and females

Inclusion Criterias

Adequate bone marrow, liver, and renal function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
Adequate bone marrow, liver, and renal function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard

Exclusion Criterias

Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
History of severe allergic reactions to monoclonal antibody therapy
Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
History of severe allergic reactions to monoclonal antibody therapy
Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management

Locations

Chuo-ku, Tokyo, 104-0045
Singapore, 119074
Singapore, 169610
Seoul, 138-736
Kashiwa, Chiba, 277-8577
...
Chuo-ku, Tokyo, 104-0045
Singapore, 119074
Singapore, 169610
Seoul, 138-736
Kashiwa, Chiba, 277-8577
Fukuoka, 811-1395
Kita-Adachigun, Saitama, 362-0806
Koto-ku, Tokyo, 135-8550

Tracking Information

NCT #
NCT01881217
Collaborators
Not Provided
Investigators
Study Director: Bayer Study Director Bayer