Anticancer Activity of Nicotinamide on Lung Cancer

January 23, 2020 updated by: Il Yeong Park, Ph.D.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chonnam
      • Hwasun, Chonnam, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Amina-X

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: two year
chi-square test of complete response and partial response (RECIST 1.1)
two year
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)
two year
Overall survival
Time Frame: two year
Cox regression analysis
two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Il Yeong Park, Ph.D.

Investigators

  • Study Director: Il Yeong Park, PhD, Chungbuk National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amina-X-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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