Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia

Titre officiel

A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

Sommaire:

Cette étude a pour objet de déterminer si les patients atteints d’un cancer avancé qui reçoivent une solution d’OHR/AVR118 par injection cutanée peuvent améliorer leur qualité de vie. Selon une étude antérieure chez des patients atteints du SIDA, les avantages possibles peuvent comprendre une augmentation de l’appétit et de la force, un gain de poids, une amélioration de l’humeur et une diminution de la fatigue.

Description de l'essai

Primary Outcome:

• Alleviation of multiple cachexia symptoms

Secondary Outcome:

• Impact on inflammatory markers and hormonal milieu

Advanced cancers are usually debilitating. There are few treatments available for symptoms of advanced cancers like loss of appetite, decreased strength, fatigue, and change in mood. This Phase II, open label study with OHR/AVR118 will enable the Sponsor to gather data on safety and efficacy of OHR/AVR118 in the patient population with anorexia-cachexia. Patients aged 18-85 with advanced cancers (excluding central nervous system [CNS] cancers) who may or may not be receiving chemotherapy, may be eligible to participate. The study drug, 4.0 mL, will be given subcutaneously each day for 28 days. Patients who respond to the trial period dosing will be eligible to continue on OHR/AVR118 if they and their physicians believe it would be beneficial, and if no safety concerns are raised.

Voir cet essai sur ClinicalTrials.gov