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
  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:


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:
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 April 15, 2014