A Phase 1/2 interventional study of MOC31PE Immunotoxin in Colorectal Neoplasms, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by Oslo University Hospital · Phase 1/2, Interventional, and Treatment
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).
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.
5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 15 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
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Laboratory values at inclusion:
Exclusion criteria:
Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.
Drug: MOC31PE Immunotoxin
Patients who meet inclusion criteria will be treated with a single intraperitoneal MOC31PE immunotoxin instillation for 6 hours on the first day after CRS and HIPEC
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Follow-up: 5 years from administration of study drug, or until disease progression
Time frame: 5 years or until disease progression
Cmax, Tmax
Measurements will be done at 0, 3, 6, 12, 24, 48 and 72 hours after administration of study drug
Time frame: 8 weeks
Neutralizing anti-immunotoxin antibody response
Measurements of neutralizing anti-immunotoxin antibody response will be done at 4 and 8 weeks after administration of study drug
Time frame: 8 weeks
Biomarkers of disease recurrence
Serum samples for identification of biomarkers of disease recurrence will be taken at every follow-up for 5 years or until disease progression
Time frame: 5 years or until disease progression
Overall survival
Overall survival of all patients will be assessed after 5 years
Time frame: 5 years
Disease free survival
Follow up period of 5 years, or until disease progression
Time frame: 5 years
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital