A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Metastatic Colorectal Cancer

In brief

The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.

Key facts

Study ID

NCT01767857

Run by

Janssen Research & Development, LLC

People needed

643

Starts

2013-03-31

Expected to finish

2017-06-30

Last updated by the study team

2021-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype.
• Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
• At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.
• Age ≥ 18 years, male or female subjects.
• Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
• Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.
• Adequate hepatic function
• Adequate bone marrow function
• For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
• Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
• Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.

You may not qualify if…

• Mechanical obstruction that would prevent adequate oral nutritional intake.
• Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
• Uncontrolled or significant cardiovascular disease, including:
• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
• Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy.
• Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
• Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.
• History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
• Receipt of a live (attenuated) vaccine within 1 month prior to Screening
• Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of XILONIX™.
• Women who are pregnant or breastfeeding.
• WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication.
• Weight loss >20% in the previous 6 months.

Where it is running

• Southern Cancer Center, PC — Mobile, Alabama, United States
• Northwest Alabama Cancer Center, PC — Muscle Shoals, Alabama, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• California Cancer Associates for Research and Excellence, Inc. (cCARE) — Fresno, California, United States
• St. Jude Medical Center — Fullerton, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• USC Norris Comprehensive Cancer Center and LAC USC Medical Center — Los Angeles, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• American Institute of Research — Whittier, California, United States
• Advanced Medical Specialists — Miami, Florida, United States
• Lewis Hall Singletary Oncology Center — Thomasville, Georgia, United States
• Swedish Covenant Hospital via Clintell, Inc. — Chicago, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Hines VA Hospital — Hines, Illinois, United States
• Oncology Specialists, SC — Park Ridge, Illinois, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• Hutchinson Clinic, P.A. — Hutchinson, Kansas, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC. — Bethesda, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Park Nicollet — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Alabama Oncology, Bruno Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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