Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03732781
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2018-11-05
Brief Title:
Study of Radspherin in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC
Sponsor:
Oncoinvent AS
Organization:
Oncoinvent AS
Study Overview
Official Title:
A Phase 12a 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 12a 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
The study consists of three different cohorts
Dose escalation cohorts
Repeated injection cohorts
Expansion cohort
Detailed 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 activityclinical 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
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 activityclinical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002803-33 | EUDRACT_NUMBER | None | None |