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The purpose of this study is to determine whether patients with advanced cancers who receive OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a previous study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain, improved mood; and decreased fatigue.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OHR/AVR118 | Experimental | Experimental Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OHR/AVR118 | Drug | OHR/AVR118 given subcutaneously at 4mL per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alleviation of multiple cachexia symptoms | Functional Status/Quality of Life as assessed by Simmonds Functional Assessment (SFA); Appetite and early satiety as assesed by patetient-generated subjective global assessment (PG-SGA), Edmonton Symptom assessment Scale (ESAS) and dyspepsia symptom severity index (DSSI); weight gain; increase in lean body mass. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on inflammatory markers and hormonal milieu | Measurement of effects on Testosterone, TSH and C-Reactive protein | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Chasen, MBChB | Ottawa Hospital Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D000855 | Anorexia |
| D015431 | Weight Loss |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| C469610 | EOM613 |
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| D001835 | Body Weight |