Clinical Trial: NCT02416739 - My Cancer Genome

NCT02416739

Description:

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.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

URL:

https://clinicaltrials.gov/show/NCT02416739

Trial Eligibility

Document

Title

Brief Title: Anticancer Activity of Nicotinamide on Lung Cancer
Official Title: 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

Clinical Trial IDs

ORG STUDY ID: Amina-X-002
NCT ID: NCT02416739

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

Drug	Synonyms	Arms
Nicotinamide	Amina-X	Nicotinamide

Purpose

Detailed Description

      The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive
      non-small-cell lung cancer patients who are not eligible to operation is to administer
      EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). To determine the
      effectiveness of nicotinamide on lung cancer, nicotinamide or placebo tablet will be
      co-administered with gefitinib or erlotinib for two years until the event or censoring
      occurs. The stratified block randomization was designed with 3 covariates (EGFR mutation
      status, kind of EGFR-TKI, ECOG (Eastern Cooperative Oncology Group) performance status score
      variation). The size of lesions will be checked every other months by radiology. PD
      (progressive disease) will be assessed according to RECIST(Response Evaluation Criteria in
      Solid Tumors)1.1. After observing 36 events, an interim analysis of hazard ratio by Cox
      proportional hazard regression will be performed. The final analysis will be done by the same
      protocol after observation of 72 events. The significance level of the interim and final
      analysis were set to 0.0075 and 0.0209 respectively. Response rate, quality of life (measured
      by 10 questions at every visit), and overall survival will be analysed together. All other
      adverse reactions will be analysed and reported, if there.

Trial Arms

Name	Type	Description	Interventions
Nicotinamide	Experimental	Nicotinamide with EGFR-TKI: gefitinib (250mg tab) or erlotinib (150mg tab) - per oral, once a day nicotinamide (500mg tab) - per oral, twice a day, until the event or censoring occurs	Nicotinamide
Placebo	Placebo Comparator	Placebo tablet with EGFR-TKI: gefitinib (250mg tab) or erlotinib (150mg tab) - per oral, once a day placebo tablet - per oral, twice a day, until the event or censoring occurs	Nicotinamide

Eligibility 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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Hazard ratio (PFS) of the nicotinamide arm to the placebo arm
Time Frame:	two year
Safety Issue:
Description:	Cox regression analysis

Secondary Outcome Measures

Measure:	Response rate
Time Frame:	two year
Safety Issue:
Description:	chi-square test of complete response and partial response (RECIST 1.1)

Measure:	Difference in quality of life between the nicotinamide arm and the placebo arm
Time Frame:	two year
Safety Issue:
Description:	measured by the cancer-related QOL questionaire response (questioned at each visit)

Measure:	Overall survival
Time Frame:	two year
Safety Issue:
Description:	Cox regression analysis

Details

Phase:	Phase 2/Phase 3
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Il Yeong Park, Ph.D.

Trial Keywords

EGFR mutated lung cancer

Last Updated

January 27, 2020

Clinical Trials /

Anticancer Activity of Nicotinamide on Lung Cancer