Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC
NCT07399015 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-02-18
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
Conditions
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- Unresectable Pancreatic Ductal Adenocarcinoma
- Metastatic PDAC
Interventions
- DRUG
-
mifomelatide
Eligible participants will receive 25 mg mifomelatide daily by subcutaneous (SC) injection for up to 13 weeks.
Sponsors & Collaborators
-
Endevica Bio
lead INDUSTRY
Principal Investigators
-
Meghan Joly, PhD · Endevica Bio
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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