Anticancer Activity of Nicotinamide on Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Il Yeong Park, Ph.D.
• Treatments: Erlotinib Hydrochloride; Gefitinib; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy

• EGFR mutated (exon 19 deletion or L858R mutation)

• Life expectation more than 3 months

• More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously

• ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2

• Who signed the informed consent form

Exclusion Criteria:

• Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy

• Who has metastasized brain lesion that needs operation or radiation therapy

• Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney

• Who does Not agree to contraception

• Who has allergy to nicotinamide