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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01186601
First received: August 20, 2010
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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.


Condition Intervention Phase
Neoplasms
 Drug: PET tracer (BAY94-9392)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology. [ Time Frame: Day 1 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Standardized uptake value (SUV) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Standardized uptake value ratio (SUVR) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
  • Laboratory Findings [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs) [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
  • Adverse Event Collection [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: PET tracer (BAY94-9392)
A radioactive dose of 300 MBq of the study drug with a total quantity of </= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186601

Locations
United States, California
Stanford, California, United States, 94305
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01186601     History of Changes
Other Study ID Numbers: 15329
Study First Received: August 20, 2010
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Piramal Imaging SA:
Prostatic Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Melanoma
Neoplasm Metastasis

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013