Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC (NCT07399015) | Clinical Trial Compass
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Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC
Plain-language summary
An expanded access program (EAP) allows doctors to give medicine to seriously ill patients before it is approved by local regulatory agencies.
The goal of this Expanded Access Protocol is to provide access to mifomelatide for eligible cachectic adult patients with advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) who lack satisfactory therapeutic alternatives for their cancer cachexia and are not eligible for current mifomelatide clinical trials.
A participant may receive mifomelatide under this EAP if:
* A licensed doctor submits a request,
* The participant is eligible
* The country allows the EAP
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be at least 18 years of age
. Documented histologic or cytologic diagnosis of advanced, unresectable PDAC
. 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:
. Weight loss of at least 5%
. Weight loss of at least 2% together with a BMI \<20 kg/m2 and/or
. Weight loss of at least 2% together with sarcopenia
. Eastern Cooperative Oncology Group (ECOG) status of ≤ 3 and life expectancy ≥ 4 months
. Lack of satisfactory therapeutic alternatives for their cancer cachexia
Exclusion criteria
. Patients with BMI \> 35
. Known hypersensitivity to mifomelatide or its formulation
. Significant medical conditions or illnesses that might increase the risk-benefit ratio of participating in this EAP as determined by the
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.