Trial Condition(s):

Neoplasms

Exploration of tumor accumulation of BAY94-9392 in patients with cancer

Bayer Identifier:

15329

ClinicalTrials.gov Identifier:

NCT01186601

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 </= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.

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

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
PET tracer (BAY94-9392)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Stanford Hospital & Clinics

Stanford, United States, 94305

Status
Completed
 

Trial Design