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Inhaled PPP011 (Caumz) for cancer cachexia
NCT04001010Phase 3
Key facts
- Status
- Suspended
- Start
- Jul 2022
- Primary completion
- Jul 2023
- Countries
- 1
- Sponsor
- Tetra Bio-Pharma Inc.
- Modality
- Small Molecules
- Drugs
- Caumz
- Conditions
- cancer cachexia
01
Overview
Phase 3, randomised, double-blind trial in cancer cachexia comparing inhaled THC/CBD (PPP011) with Placebo (2 arms). Primary endpoints: Physical functioning (EORTC-QLQ-C15-PAL) at 12 weeks and Cachexia grade at 12 weeks. Started Jul 2022; status: suspended.
02
Design
2 arms- Study design
- RandomizedDouble-blind
inhaled THC/CBD (PPP011)
PPP011 (synthetic THC/CBD) inhalation with mighty medic device, 1 capsule 3 times a day
Placebo
Placebo inhalation with mighty medic device, 1 capsule 3 times a day
03
Who it enrols
Adult patients with advanced cancer and no curative therapy options, suffering from Grade 2 or 3 cachexia (weight loss) in the last 6 months. Patients must have a Karnofsky Performance Status >= 60%, FEV1 > 60%, and life expectancy of at least 4 months.
04
Endpoints
Primary
Physical functioning (EORTC-QLQ-C15-PAL)
Cachexia grade
Secondary
Pain Visual Analog Scale
Patient-Generated Subjective Global Assessment (PG-SGA)
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