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

Summary

Participation Requirements

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 hy...

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 39. Subjects who discontinue prior to Radspherin® administration will be replaced. Dose escalation cohorts (Phase 1a): 3 - 24 subjects Repeated injection cohorts (Phase 1b): 3 - 9 subjects Expansion cohort: 6 subjects

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