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Anticancer Activity of Nicotinamide on Lung Cancer

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ClinicalTrials.gov Identifier: NCT02416739
Recruitment Status : Unknown
Verified January 2020 by Il Yeong Park, Ph.D., Chungbuk National University.
Recruitment status was:  Active, not recruiting
First Posted : April 15, 2015
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Il Yeong Park, Ph.D., Chungbuk National University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: Nicotinamide Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nicotinamide

Nicotinamide with EGFR-TKI:

  1. gefitinib (250mg tab) or erlotinib (150mg tab) - per oral, once a day
  2. nicotinamide (500mg tab) - per oral, twice a day, until the event or censoring occurs
 Drug: Nicotinamide
Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients
Other Name: Amina-X
Placebo Comparator: Placebo

Placebo tablet with EGFR-TKI:

  1. gefitinib (250mg tab) or erlotinib (150mg tab) - per oral, once a day
  2. placebo tablet - per oral, twice a day, until the event or censoring occurs
 Drug: Nicotinamide
Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients
Other Name: Amina-X


Outcome Measures
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Primary Outcome Measures :
  1. Hazard ratio (PFS) of the nicotinamide arm to the placebo arm [ Time Frame: two year ]
    Cox regression analysis


Secondary Outcome Measures :
  1. Response rate [ Time Frame: two year ]
    chi-square test of complete response and partial response (RECIST 1.1)

  2. Difference in quality of life between the nicotinamide arm and the placebo arm [ Time Frame: two year ]
    measured by the cancer-related QOL questionaire response (questioned at each visit)

  3. Overall survival [ Time Frame: two year ]
    Cox regression analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416739


Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, Korea, Republic of, 58128
Sponsors and Collaborators
Il Yeong Park, Ph.D.
Investigators
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Study Director: Il Yeong Park, PhD Chungbuk National University
More Information
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Publications:

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Responsible Party: Il Yeong Park, Ph.D., Professor, Chungbuk National University
ClinicalTrials.gov Identifier: NCT02416739    
Other Study ID Numbers: Amina-X-002
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Il Yeong Park, Ph.D., Chungbuk National University:
EGFR mutated lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Niacinamide
 Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents