Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy
Summary
This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 120 patients with newly diagnosed locally advanced, unresectable or metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (≤ 29 kg/m\^2). Treatment will start at the second cycle of first-line cancer chemotherapy and continue for 12-weeks with the goal of maintaining body weight and muscle mass in patients undergoing chemotherapy relative to control.
Arms & interventions
- DrugTCMCB07
TCMCB07 is will be provided in single-use vials for subcutaneous administration
- DrugPlacebo
Matching placebo
Outcome measures
Primary
Change from baseline in body weight
Time frame: At 12 weeks of treatment
Incidence and severity of adverse events (AEs)
Time frame: From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in laboratory evaluations
Time frame: From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in vital signs
Time frame: From enrollment to the end of the 12 week dosing period
Secondary
Change from baseline in total score of Functional Assessment of Anorexia/Cachexia Therapy-anorexia-related symptoms scale (FAACT-5IASS)
Time frame: At 12 weeks of treatment
Change from baseline in the anorexia and cachexia subscore of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) questionnaire
Time frame: At 12 weeks of treatment
Change from baseline in BMI
Time frame: At 12 weeks of treatment
Change from baseline in body weight
Time frame: At 8 weeks of treatment
Change from baseline in BMI
Time frame: At 8 weeks of treatment
Change from baseline in body weight
Time frame: At 4 weeks of treatment
Change from baseline in BMI
Time frame: At 4 weeks of treatment
Change from baseline in the FAACT questionnaire comprising the general quality of life FAACT-G and FAACT-ACS anorexia and cachexia related subscale
Time frame: At 12 weeks of treatment
Change from baseline in total score and subscores of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: At 12 weeks of treatment
Eligibility criteria
Study locations (25)
Investigative Site
Tucson, Arizona, 85715
Investigative Site
Los Angeles, California, 90048
Investigative Site
Los Angeles, California, 90095
Investigative site
Coral Springs, Florida, 33071
Investigative Site
Hialeah, Florida, 33013
Investigative Site
Margate, Florida, 33063
Investigative Site
Miami Beach, Florida, 33140
Investigative Site
Tamarac, Florida, 33321
Investigative Site
Atlanta, Georgia, 30318
Investigative Site
Chicago, Illinois, 60611
Investigative Site
Hinsdale, Illinois, 60521
Investigative Site
Skokie, Illinois, 60077
Investigative Site
Wichita, Kansas, 67214
Investigative Site
Detroit, Michigan, 48201
Investigative Site
Lincoln, Nebraska, 68506
Investigative Site
Omaha, Nebraska, 68130
Investigative Site
New York, New York, 10016
Investigative Site
Durham, North Carolina, 27710
Investigative Site
Oklahoma City, Oklahoma, 73102
Investigative Site
Charleston, South Carolina, 29425
Investigative Site
Memphis, Tennessee, 38120
Investigative site
Nashville, Tennessee, 37232
Investigative Site
Kingwood, Texas, 77090
Investigative Site
Laredo, Texas, 78041
Investigative Site
Charlottesville, Virginia, 22908