Status:
COMPLETED
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjec...
Eligibility Criteria
Inclusion
- 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
- Adequate bone marrow, liver, and renal function.
- For subjects in the additional cohort:
- Subjects with advanced, histologically or cytologically confirmed gastric cancer.
- At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed
Exclusion
- 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
Key Trial Info
Start Date :
June 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01881217
Start Date
June 28 2013
End Date
August 16 2016
Last Update
September 14 2017
Active Locations (8)
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1
Kashiwa, Chiba, Japan, 277-8577
2
Kita-Adachigun, Saitama, Japan, 362-0806
3
Chuo-ku, Tokyo, Japan, 104-0045
4
Koto-ku, Tokyo, Japan, 135-8550