Trial Condition(s):

Neoplasms

First-in-man dose escalation study of BAY1179470 in patients with advanced, refractory solid tumors

Bayer Identifier:

16182

ClinicalTrials.gov Identifier:

NCT01881217

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 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
 - 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 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

Trial Summary

Enrollment Goal
35
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY117-9470
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Investigative Site

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Investigative Site

Kita-Adachigun, Japan, 362-0806

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 811-1395

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119074

Status
Terminated
 
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Completed
 

Trial Design