Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01103310 | Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation | PHASE1 | COMPLETED | 46 | — | — | Apr 1, 2010 | Aug 1, 2011 | Nov 13, 2014 | 3 | United States, Germany +1 |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT |
| Arm 2 | EXPERIMENTAL | Healthy 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 |
| Name | Type | Description |
|---|---|---|
| BAY94-9392 | DRUG | - |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hologic, Inc. | HOLX | 1 | NA | Undisclosed |
| Intelligent Bio Solutions Inc. | INBS | 1 | — | Undisclosed |
| HeartFlow, Inc. | HTFL | 1 | NA | Rosuvastatin |
| GE Healthcare Technologies Inc. | GEHC | 2 | NA | Undisclosed |
| Unity Health Toronto | UBX | 1 | — | Undisclosed |