stop_circleTerminated/Withdrawn

Neoplasms

Clinical study to evaluate the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors

Trial purpose

Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY79-4620 given every 2 weeks to patients with advanced solid tumors

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
2
Trial Dates
April 2010 - August 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY79-4620
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
University Medical Center UtrechtUTRECHT, 3584 CX, Netherlands
Terminated
Erasmus Medisch CentrumROTTERDAM, 3075 EA, Netherlands

Primary Outcome

  • Adverse Event reporting
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
    enhanced_encryption
    Safety Issue:
    yes
  • Pharmacokinetics profile of BAY79-4620
    date_rangeTime Frame:
    End of cycle 2 (14 days per cycle)
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    Safety Issue:
    yes

Secondary Outcome

  • Biomarkers evaluation
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
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    Safety Issue:
    yes
  • Tumor response evaluation
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
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    Safety Issue:
    yes
  • Immunogenicity evaluation
    date_rangeTime Frame:
    Approximately 3 years after initiation of the trial
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    Safety Issue:
    yes

Trial design

An open label Phase I dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY79-4620 administered as an intravenous infusion once every 2 weeks in patients with advanced solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1