check_circleStudy Completed

Neoplasms

To determine maximum tolerated dose of BAY79-4620 in patients with advanced solid tumors

Trial purpose

This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be investigated:
- side effects of BAY79-4620 given as infusion every three weeks
- evaluation of highest and safest dose of BAY79-4620
- distribution and concentration of BAY79-4620 in the blood at specific times after administration
- effect of BAY79-4620 on tumor growth
- assessment of "biomarkers” (eg, analysis of specific proteins in blood samples, or analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the treatment or prediction of safety or benefits of the treatment with BAY79-4620.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
12
Trial Dates
November 2009 - April 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY79-4620
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
South Texas Accelerated Research Therapeutics, LLCSan Antonio, 78229-3307, United States
Completed
Sarah Cannon Cancer CenterNashville, 37203, United States

Primary Outcome

  • Safety, tolerability, maximum tolerated dose
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    yes
  • Pharmacokinetics profile of BAY79-4620 and its key metabolites
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Biomarker evaluation
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    no
  • Tumor response
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    no
  • Immunogenicity
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    no

Trial design

An open label Phase I study to evaluate the safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY79-4620 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