A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer

NCT01915472 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-08-19

No results posted yet for this study

Summary

This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don't belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe and effective.

Conditions

Interventions

DRUG

IMMU 130

This is a Phase II, open-label study of IMMU-130 administered every 14 days for a period of 24 weeks to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01915472 on ClinicalTrials.gov