A Study Evaluating Xilonix in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy

Primary Efficacy Endpoint: • The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (≥0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (≥0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30. Primary endpoints: The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (≥0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (≥0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30.