Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 5:07 AM
Study NCT ID:
NCT02219893
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2014-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-05
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:
ImmunoPeCa
Brief Summary:
The purpose of this study is through a phase I/II clinical trial to assess the safety and toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for peritoneal metastases from colorectal cancer (CRC).
Detailed Description:
MOC31PE is an immunotoxin that has previously been evaluated in a phase I clinical study involving patients with advanced EpCAM positive carcinoma to assess the safety and tolerability profile and the pharmacokinetic behavior of the compound. In this study, the compound was administered intravenously and was well tolerated. MOC31PE will now be evaluated on the same parameters in a new phase I/II clinical trial, where the drug will be administered intraperitoneally to patients with peritoneal metastases from EpCAM positive colorectal carcinomas.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: