Experimental drug offered to cancer patients with severe wasting
NCT ID NCT07399015
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This expanded access program gives seriously ill adults with advanced pancreatic cancer and cachexia (severe weight loss and muscle wasting) access to the experimental drug mifomelatide. Patients receive a daily injection for up to 13 weeks. The goal is to provide a potential treatment option when no others are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mifomelatide
- What this could lead to
- If it works, this could help reduce severe weight loss and muscle wasting in people with advanced pancreatic cancer.
- What could go wrong
- This is an expanded access program, not a formal trial, so results are not systematically collected. It is only for patients with no other options, and the drug may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Must be at least 18 years of age 2. Documented histologic or cytologic diagnosis of advanced, unresectable PDAC 3. Current cachexia (documented in medical records) as defined by Fearon criteria based on at least one of the following three weight loss conditions in the 6 months prior to enrollment: 1. Weight loss of at least 5% 2. Weight loss of at least 2% together with a BMI \<20 kg/m2 and/or 3. Weight loss of at least 2% together with sarcopenia 4. Eastern Cooperative Oncology Group (ECOG) status of ≤ 3 and life expectancy ≥ 4 months 5. Lack of satisfactory therapeutic alternatives for their cancer cachexia 6. Willing and able to safely self-inject or be injected by a caregiver daily 7. Not eligible to participate in ongoing clinical trials of the investigational drug 8. Willing and able to sign informed consent Exclusion Criteria: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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