Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC

Exclusion Criteria

• •8. Willing and able to sign informed consent
• •1. Patients with BMI \> 35
• •2. Known hypersensitivity to mifomelatide or its formulation
• •3. Significant medical conditions or illnesses that might increase the risk-benefit ratio of participating in this EAP as determined by the
• •Treating Physician, which may include:
• •* Patients with swallowing abnormalities, malabsorption syndromes, severe short or inflammatory bowel syndromes, or other conditions that in the Treating Physician's opinion could impair food consumption or metabolism
• •* Receiving exclusive tube feeding or parenteral nutrition at the time of enrollment
• •* History of weight loss surgery including gastric stapling, or bypass
• •* ANC \< 1.5 x 109/L
• •* AST and/or ALT \> 3 x ULN (\> 5 x ULN in the presence of documented liver metastases)
• •* Total bilirubin \> 1.5 x ULN (\> 3 x ULN in the presence of documented Gilbert's Syndrome)
• •* Creatinine clearance calculated by Cockcroft and Gault equation \< 50 mL/min Uncontrolled diabetes defined as HbA1c \>7%
• •4. Currently pregnant, breastfeeding or planning to become pregnant