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Randomized Double-blinded Comparative Trial to Study the Add-on Activity of Combination Treatment of Nicotinamide on Progression Free Survival for EGFR Mutated Lung Cancer Terminal Stage Patients Being Treated With Gefitinib or Erlotinib
Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer cells. Nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.
Details
| Lead sponsor | Il Yeong Park, Ph.D. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | UNKNOWN |
| Enrolment | 110 |
| Start date | 2015-03 |
| Completion | 2020-06 |
Conditions
- Non-Small-Cell Lung Carcinoma
Interventions
- Nicotinamide
Primary outcomes
- Hazard ratio (PFS) of the nicotinamide arm to the placebo arm — two year
Cox regression analysis
Countries
South Korea