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Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC

Colorectal Carcinoma Clinical Trial

Official title:
A Phase 1/2a Study to Evaluate the Dose, Safety and Tolerability and Efficacy of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Subjects With Peritoneal Carcinomatosis From Colorectal Carcinoma Following Hyperthermic Intraperitoneal Chemotherapy

Clinical Trial Summary

This is a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP α-emitting radionuclide therapy (Radspherin®) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma following complete CRS (cytoreduction score CC-0) and HIPEC. The study consists of three different cohorts: - Dose escalation cohorts - Repeated injection cohorts - Expansion cohort

Clinical Trial Description

Primary objectives: - To investigate safety and toxicity of Radspherin® - To determine the maximum-tolerated dose (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) and hyperthermic IP chemotherapy (HIPEC) Secondary objectives: - To establish a recommended dose of Radspherin® as a single IP injection and two repeated IP injections following CRS and HIPEC - To describe the biodistribution of Radspherin® - To examine the efficacy and clinical benefit of Radspherin® following CRS and HIPEC Exploratory objectives: - To explore the association of biomarkers with activity/clinical benefits, adverse events (AEs), or other effects associated with Radspherin® - To explore effects of catheter placement, Radspherin® administration technique, and infusion volume on the distribution of 224Ra labelled micro particles in the peritoneal cavity The maximum number of subjects receiving Radspherin® in this study is 67. Subjects who discontinue prior to Radspherin® administration will be replaced. Dose escalation cohorts: 3 - 24 subjects Repeated injection cohorts: 3 subjects Expansion cohort: up to 40 subjects ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03732781
Study type Interventional
Source Oncoinvent AS
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date May 27, 2020
Completion date February 2025
View Details
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