Neoplasms

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Symptoms and General Pathology

Wounds and Injuries

Digestive System Diseases

Carcinoma

Hyperthermia

Fever

Colorectal Neoplasms

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Abdominal Neoplasms

Peritoneal Diseases

All Drugs and Chemicals

Gastrointestinal Agents

Bone Density Conservation Agents

Calcium

Calcium Carbonate

Calcium, Dietary

Radspherin® suspension consists of degradable calcium carbonate microparticles with the α-emitting radionuclide 224Ra in suspension.

Radspherin® will be provided in a R10 vial filled with 10 mL suspension of 224Ra adsorbed on 1 g calcium carbonate microparticles. The volume to be administered will contain 0.7-1 g calcium carbonate microparticles with 1-7 MBq 224Ra. 224Ra has a half-life of 3.6 days.

Radspherin

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

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

3+3 Dose escalation with expansion cohort

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

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

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)

Oncoinvent AS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC	NCT03732781	Peritoneal Carc... Colorectal Carc...	Radspherin	18 Years -	Oncoinvent AS
Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC	NCT03732781	Peritoneal Carc... Colorectal Carc...	Radspherin	18 Years -	Oncoinvent AS

Spots Global Cancer Trial Database for radspherin

Every month we try and update this database with for radspherin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for radspherin

Every month we try and update this database with for radspherin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for radspherin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.