Status:
COMPLETED
Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
Lead Sponsor:
Life Molecular Imaging SA
Conditions:
Neoplasms
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear med...
Eligibility Criteria
Inclusion
- Males/females \>/= 18 years
- Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392
- Patient had an \[18F\]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head \& neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
- No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
Exclusion
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- Known sensitivity to the study drug or components of the preparation
- Previous treatment with BAY94-9392 in this study
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01186601
Start Date
December 1 2010
End Date
October 1 2011
Last Update
November 13 2014
Active Locations (1)
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1
Stanford, California, United States, 94305