Name (Synonyms) | Correlation | |
---|---|---|
D000077216 | Carcinoma, Ovarian Epithelial NIH | 1.00 |
D010534 | Peritoneal Neoplasms NIH | 1.00 |
D010051 | Ovarian Neoplasms NIH | 0.71 |
D002277 | Carcinoma NIH | 0.45 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0100615 | Ovarian neoplasm HPO | 0.71 |
HP:0030731 | Carcinoma HPO | 0.45 |
There is one clinical trial.
RAD-18-001 is a First-In-Man, Dose Escaltion study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Acceptability of up to 7 MBq gives the opportunity to explore the doses of the dose escalation split into two administrations, and given as two separate injections 1 week apart. Split doses of 1, 2 and 3.5 MBq will be administered as two injections. Each subject will be followed until disease progression (in the abdominal cavity), or for 12 months after the administration of Radspherin® (whichever comes first).
Description: To investigate safety and toxicity of Radspherin®
Measure: Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0. Time: 12 monthsDescription: To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)
Measure: Maximum Tolerated Dose (MTD) Time: 21 days