Matrix Biomed, Inc.
Treatment of Metastatic Cancer in Terminally Diagnosed Patients
Conditions: Metastatic Cancer
The objective is to provide terminally diagnosed patients with a last line of treatmentwhile improving overall quality of life. Tempol can be added to any chemotherapy regimento potentially reduce side effects and overcome chemoresistance.
DBV Technologies
Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
Conditions: Peanut Allergy
This is an open label expanded access program for male and female patients 2 years orolder, to provide continued desensitization treatment with DBV712 250 mcg.
Neuraptive Therapeutics Inc.
NTX-001 to Repair Peripheral Nerve Transection(s)
Conditions: Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves
The proposed use of NTX-001 for transections of upper extremity and facial peripheralnerves, acutely or planned.
Celcuity Inc
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Conditions: Breast Neoplasm Malignant Female
Continued access to treatment for subjects who continue benefit from therapy withgedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Bristol-Myers Squibb
Expanded Access for Apixaban
Conditions:
This is an expanded access designed to provide access to apixaban for eligibleparticipants.
Novo Nordisk A/S
Compassionate Use of Concizumab if You Have Haemophilia
Conditions: Congenital Haemophilia
The compassionate use programme will give participants concizumab for free, even thoughit is not yet approved by health authorities. This is because participants need thismedicine to treat their haemophilia properly. The programme will check that participantsare safe and that the medicine works for them. The programme may last for years.Participants will take one injection under their skin every day. Participants will have4-5 visits with the study doctor for the first half year. After that they will have 1visit every half year. At all clinic visits participants will have blood samples taken.Participants will fill in a diary between the visits.A patient is considered to have completed the programme when any of the followingcriteria occurred first: 1) when the patient is included in a clinical trial withconcizumab or 2) up to 6 months after concizumab is commercially available in thepatient's country and approved for the patient (The time span of 6 months should provideample time for the patient to obtain concizumab commercially) or 3) the sponsor decidesto discontinue concizumab clinical development for the patient's population.
Giselle Sholler
An Intermediate Expanded Use Trial of DFMO
Conditions: Neuroblastoma, Medulloblastoma, Typical Teratoid Rhabdoid Tumor, Embryonal Tumor With Abundant Neuropil and True Rosettes, Ependymoblastoma, Medulloepithelioma
To provide DFMO in an expanded use setting to subjects with relapsed rare tumors withincreased LIN28 expression or MYCN amplification or up regulation of ornithinedecarboxylase.
Cook MyoSite
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
Conditions:
This is an expanded access program (EAP) for eligible participants designed to provideaccess to autologous muscle derived cells (AMDCs). Treating physicians may submitrequests for expanded access to Cook MyoSite's investigational product by email toMYO-ExpandedAccess@CookMyoSite.com.
Vanda Pharmaceuticals
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Conditions: Gastroparesis, Diabetic Gastroparesis
Primary Objective: To treat a single patient with gastroparesis who has requestedexpanded access with tradipitant