check_circleStudy 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
  • - 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.
  • - 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
December 2010 - October 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
PET tracer (BAY94-9392)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Stanford Hospital & ClinicsStanford, 94305, United States

Primary Outcome

  • Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Day 1
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    Safety Issue:
    Yes

Secondary Outcome

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

Additional Information

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