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Omeprazole with Chemotherapy in Head and Neck Cancer
NCT02013453Phase 2
Key facts
- Status
- Withdrawn
- Start
- Dec 2013
- Primary completion
- Dec 2016
- Countries
- 1
- Sponsor
- University of Michigan Rogel Cancer Center
- Modality
- Small Molecules
- Drugs
- omeprazole
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, randomised, double-blind trial of omeprazole in head and neck squamous cell carcinoma (HNSCC) (3 arms), sponsored by University of Michigan Rogel Cancer Center. Primary endpoint: Time to progression. Planned start Dec 2013; status: withdrawn.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Observational
Patients already on PPI receive Standard Chemo + Omeprazole
Standard Chemo + Placebo
Patients not on PPI randomized to Standard Chemo + Placebo
Standard Chemo + Omeprazole
Patients not on PPI randomized to Standard Chemo + Omeprazole
03
Who it enrols
Patients with recurrent or metastatic SCCHN, ECOG 0-1, and adequate organ function. Patients already on PPIs enter observational arm; others are randomized.
04
Endpoints
Primary
Time to progression
Secondary
Median overall survival
Proportion of patients that experience a response to treatment
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