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Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

Ovarian Cancer Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Dose, Safety and Tolerability of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis Following CRS

Clinical Trial Summary

RAD-18-001 is a First-In-Man, Dose Escalation 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. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first). In the expansion cohort the subject will receive the recommended dose. The expansion cohort will be conducted at 4 sites. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

Clinical Trial Description

The maximum number of subjects enrolled in this study is 49. The following number of subjects will be recruited in the different cohorts: - Dose escalation cohorts: 3 - 24 Subjects - Expansion cohort: Up to 25 Subjects ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03732768
Study type Interventional
Source Oncoinvent AS
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 8, 2020
Completion date August 2025
View Details
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