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Anticancer Activity of Nicotinamide on Lung Cancer

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ClinicalTrials.gov Identifier: NCT02416739
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE April 15, 2015
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
Hazard ratio (PFS) of the nicotinamide arm to the placebo arm [ Time Frame: two year ]
Cox regression analysis
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
Hazard ratio (PFS) of the nicotinamide arm to the placebo arm [ Time Frame: two year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • Response rate [ Time Frame: two year ]
    chi-square test of complete response and partial response (RECIST 1.1)
  • 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)
  • Overall survival [ Time Frame: two year ]
    Cox regression analysis
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
  • Response rate [ Time Frame: two year ]
  • Quality of life [ Time Frame: two year ]
    measured by the cancer-related QOL questionaire scores
  • Overall survival [ Time Frame: two year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticancer Activity of Nicotinamide on Lung Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Nicotinamide
  • 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
    Intervention: Drug: Nicotinamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 10, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02416739
Other Study ID Numbers  ICMJE Amina-X-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Il Yeong Park, Ph.D., Chungbuk National University
Study Sponsor  ICMJE Il Yeong Park, Ph.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Il Yeong Park, PhD Chungbuk National University
PRS Account Chungbuk National University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP