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BAY94-9392

Phase 1

Diagnostic Imaging | Small molecule | Oncology |Lantheus Holdings, Inc.|Last Updated: Nov 13, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

BAY94-9392 · 1 trial · 2 indications

Phase 1 1
NCT01103310Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or InflammationDiagnostic Imaging
COMPLETED46 Analytics
PHASE1COMPLETED
Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
Diagnostic ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual assessment of lesion
Day of study drug administration

Secondary Endpoints

Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs)
Day of study drug administration
Electrocardiogram (ECG)
At least twice within 2 days after treatment
Blood pressure
At least twice within 2 days after treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALCancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT
Arm 2EXPERIMENTALHealthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood

Interventions

NameTypeDescription
BAY94-9392DRUG -
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Eligibility Criteria

Age Range35 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion criteria: In Germany Healthy volunteers * Males/females ≥ 50 and ≤ 65 years Patients * Males/females ≥ 35 and ≤ 75 years * histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or * patient with primary prostate cancer sc...

Countries:United StatesGermanySouth Korea
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Competitive Landscape -Diagnostic and Imaging 9 trials (matched to "Diagnostic Imaging")

Frequently asked questions about BAY94-9392

What is BAY94-9392 used for?

BAY94-9392 is an investigational small molecule being developed for diagnostic imaging in oncology. It is being studied as a positron emission tomography (PET) imaging agent to visualize cancer and inflammation in patients. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does BAY94-9392 target?

BAY94-9392 is a small molecule PET imaging agent designed to detect cancer and inflammation. While its specific molecular target is not disclosed, it is being evaluated for its ability to image neoplasms and inflammatory conditions. The drug is in Phase 1 trials to assess its safety, metabolism, and imaging properties.

Who makes BAY94-9392?

BAY94-9392 is being developed by Lantheus Holdings, Inc. (NASDAQ: LNTH), a company focused on diagnostic imaging agents. The drug is currently in Phase 1 clinical development for oncology imaging applications.

What phase is BAY94-9392 in?

BAY94-9392 is in Phase 1 clinical development. A single Phase 1 trial has been completed, which evaluated the drug's radiation dosimetry, metabolism, pharmacokinetics, safety, tolerability, and PET imaging capabilities in healthy volunteers and patients with cancer or inflammation. The drug remains investigational.

What clinical trials is BAY94-9392 in?

BAY94-9392 has one completed clinical trial, NCT01103310, which enrolled 46 participants. The study assessed radiation dosimetry, metabolism, pharmacokinetics, safety, tolerability, and PET imaging in healthy volunteers and patients with cancer or inflammation. The trial was conducted in the United States, Germany, and South Korea.