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Experimental drug offered to cancer patients with severe wasting

NCT ID NCT07399015

Symptom relief Sponsor: Endevica Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

18 years and older

Sex

Anyone

Show 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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