check_circleStudy Completed
Neoplasms
Bayer Identifier:
12671
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
- 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
BothAge
18 YearsTrial summary
Enrollment Goal
12Trial Dates
November 2009 - April 2013Phase
Phase 1Could I Receive a placebo
NoProducts
BAY79-4620Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | South Texas Accelerated Research Therapeutics, LLC | San Antonio, 78229-3307, United States |
Completed | Sarah Cannon Cancer Center | Nashville, 37203, United States |
Primary Outcome
- Safety, tolerability, maximum tolerated dosedate_rangeTime Frame:2 yearsenhanced_encryptionyesSafety Issue:
- Pharmacokinetics profile of BAY79-4620 and its key metabolitesdate_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Biomarker evaluationdate_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
- Tumor responsedate_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
- Immunogenicitydate_rangeTime Frame:2 yearsenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1