Study Completed

Neoplasms

Bayer Identifier:

15329

ClinicalTrials.gov Identifier:

NCT01186601

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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

Key Participants Requirements

Sex

Both

Age

18 - 90 Years

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

Trial Dates

December 2010 - October 2011

Phase

Phase 1

Could I Receive a placebo

Products

PET tracer (BAY94-9392)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Stanford Hospital & Clinics	Stanford, 94305, United States

Primary Outcome

Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
Time Frame:
Day 1
Safety Issue:
Yes
Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis.
Time Frame:
Day 1
Safety Issue:
Yes

Secondary Outcome

Standardized uptake value (SUV)
Time Frame:
Day 1
Safety Issue:
No
Standardized uptake value ratio (SUVR)
Time Frame:
Day 1
Safety Issue:
No
Vital Signs
Time Frame:
Day 1 and Day 2
Safety Issue:
Yes
Laboratory Findings
Time Frame:
Day 1 and Day 2
Safety Issue:
Yes
Electrocardiograms (ECGs)
Time Frame:
Day 1 and Day 2
Safety Issue:
Yes
Adverse Event Collection
Time Frame:
Day 1 and Day 2
Safety Issue:
Yes

Trial design

Open-label study for an exploration of tumor accumulation of the 18F labeled PET/CT (positron emission tomography / computed tomography) tracer BAY94-9392 following a single intravenous administration of 300 MBq (corresponding to </= 0.1 mg total quantity) in patients with prostate cancer or other malignant tumors

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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