Overview

Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
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 medicine imaging examinations. The investigational drug will be given as a single administration in a dose of Phase: Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Life Molecular Imaging SA
Piramal Imaging SA
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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