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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: PET tracer (BAY94-9392)

• Registration Number: NCT01186601
• Lead Sponsor: Life Molecular Imaging SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Study Start: 2010-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	PET tracer (BAY94-9392)	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.	Day 1
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.	Day 1

Secondary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	Day 1
Standardized uptake value ratio (SUVR)	Day 1
Vital Signs	Day 1 and Day 2
Laboratory Findings	Day 1 and Day 2
Electrocardiograms (ECGs)	Day 1 and Day 2
Adverse Event Collection	Day 1 and Day 2