check_circleStudy Completed

Neoplasms

Bayer Identifier:

16182

ClinicalTrials.gov Identifier:

NCT01881217

EudraCT Number:

Not Available

EU CT Number:

Not Available
First-in-man dose escalation study of BAY1179470 in patients with advanced, refractory solid tumors

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

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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
  • - 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
June 2013 - August 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY117-9470
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kashiwa, 277-8577, Japan
Completed
Chuo-ku, 104-0045, Japan
Completed
Koto-ku, 135-8550, Japan
Completed
Kita-Adachigun, 362-0806, Japan
Completed
Fukuoka, 811-1395, Japan
Completed
Seoul, 138-736, Korea, Republic Of
Terminated
Singapore, 119074, Singapore
Completed
Singapore, 169610, Singapore

Primary Outcome

  • Number of participants with Adverse Events as a Measure of Safety and Tolerability
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470
    date_rangeTime Frame:
    Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration
    date_rangeTime Frame:
    Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Tumor response
    Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.
    date_rangeTime Frame:
    Every 42 days
    enhanced_encryption
    Safety Issue:
    No
  • Biomarker (plasma)
    date_rangeTime Frame:
    Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days
    enhanced_encryption
    Safety Issue:
    No
  • Biomarker (biopsy)
    Additional cohort only
    date_rangeTime Frame:
    Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
    enhanced_encryption
    Safety Issue:
    No
  • Immunogenicity
    Analyzed for anti-BAY 1179470 antibodies
    date_rangeTime Frame:
    Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days

Trial design

An open-label, Phase I, dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous BAY 1179470 in subjects with advanced, refractory solid tumors.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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