An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY1179470 in Subjects With Advanced, Refractory Solid Tumors
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY1179470 in Subjects With Advanced, Refractory Solid Tumors
Inclusion Criteria:
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a
life expectancy of at least 3 months
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Outcome Time Frame:
Up to 2 years
Safety Issue:
Yes
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
16182
NCT ID:
NCT01881217
Start Date:
June 2013
Completion Date:
December 2015
Related Keywords:
- Neoplasms
- Phase I
- Dose escalation
- Advanced, refractory solid tumors
- FGFR2
- Neoplasms
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