Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC
brief 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
detailed description
This is an expanded access program (EAP) providing access to mifomelatide for participants with advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) and cachexia, prior to approval by local regulatory agencies.
Availability of the EAP is dependent upon physician request, country eligibility and local/country regulations. Physicians may request access to the EAP for participants who they feel may benefit from mifomelatide and meet the eligibility criteria.
Once enrolled, participants will receive mifomelatide by subcutaneous injection once daily for up to 13 weeks.
Participants will be asked to follow the standard of care treatment for their cancer as outlined by their treating physician. Participants will be followed for safety up to 30 days after their final treatment. Physicians will be required to report safety data to Kalohexis (a spin off company from Endevica Bio).
official title
Intermediate-size Expanded Access Protocol (EAP): Mifomelatide for the Treatment of Cachexia in Adults With Advanced, Unresectable PDAC