A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer (XCITE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer|
- Overall Survival [ Time Frame: baseline to 18 months ] [ Designated as safety issue: No ]The difference in median overall survival will be compared between the two arms.
- Change in Lean Body Mass [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]Change in LBM as measured by DEXA scan will be compared between the two arms
- Quality of life questionnaire [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]EORTC-QLQ C30
- Progression Free Survival [ Time Frame: baseline to 18 months ] [ Designated as safety issue: No ]The difference in median PFS will be compared between the two arms
- Objective Response Rate [ Time Frame: baseline to 18 months ] [ Designated as safety issue: No ]The ORR will be compared between the two arms
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
MABp1 administered IV every two weeks, plus best supportive care
Xilonix is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks with best supportive care until clinical or radiographic progression.
Other Name: MABp1, CA-18C3
Placebo Comparator: Placebo
Placebo administered IV every two weeks, plus best supportive care
Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.
Other Name: Placebo
In the setting of refractory, metastatic disease a complete resolution of tumor burden is not a reasonable expectation. Instead, the primary goal of anti-tumor therapy at this stage is to eliminate or reduce the symptomatic effects of the tumor, while trying to prolong survival for as long as possible. Due to treatment related morbidity however, few treatment modalities are ideal for this objective. Even with the most recent targeted agents (such as multi-kinase inhibitors), drug related toxicities frequently lead to relatively short treatment durations. With discontinuation of therapy, disease progression is uncontrolled and prognosis is poor.
New agents that control disease progression—while improving tumor-related symptoms, rather than causing significant therapy related morbidity—are vitally needed to treat patients with advanced cancer, including those with colorectal cancer. An approach has been taken to develop such an agent using a monoclonal antibody to block the chronic inflammation involved in both malignant disease progression and constitutional symptoms.
Xilonix™ is expected to inhibit tumor growth and metastasis by interrupting crucial signals that drive angiogenesis and invasiveness. The antibody therapy may also block tumor microenvironment infiltration by leukocytes (such as myeloid suppressor cells) that suppress antitumor immunity, enabling better host immune control of the disease. In addition to local effects on the tumor, Xilonix™ is expected to work systemically to correct the metabolic dysregulation, fatigue and anxiety mediated by chronic inflammatory signaling to the central nervous system.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767857
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|Study Chair:||George Fisher, M.D., Ph.D.||Stanford University|