Clinical Trials /

Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

NCT02485652

Description:

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
  • Official Title: A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

Clinical Trial IDs

  • ORG STUDY ID: HM-EMSI-202
  • SECONDARY ID: 2015-001435-21
  • NCT ID: NCT02485652

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
HM61713OlmutinibHM61713

Purpose

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Detailed Description

      This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral
      single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with
      an EGFR-TKI as measured by objective response rate (ORR).
    

Trial Arms

NameTypeDescriptionInterventions
HM61713ExperimentalHM61713 800 mg (2 x 400 mg tablets) once daily (QD)
  • HM61713

Eligibility Criteria

        Inclusion Criteria:

          -  Age: at least 20 years of age

          -  Cytologically or histologically confirmed adenocarcinoma of locally advanced or
             metastatic NSCLC which is not amenable to curative surgery or radiotherapy

          -  Radiologically confirmed disease progression after at least one line of treatment with
             an EGFR-TKI

          -  At least one documented EGFR mutation which is known to be related with susceptibility
             to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)

          -  World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at
             least 3 months

          -  Centrally confirmed T790M mutation positive tumor status from a tumor sample taken
             after confirmation of disease progression on the most recent anticancer treatment
             regimen

          -  At least one lesion (excluding the brain), not previously irradiated that can be
             accurately measured per RECIST version 1.1

          -  Adequate hematological and biological function

          -  Females of child-bearing potential must agree to use adequate contraception and for 3
             months after the last dose of study drug

          -  Male patients should be documented to be sterile or agree to use barrier contraception

          -  Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory
             neuropathy ≤ Grade 2 and alopecia

        Exclusion Criteria:

          -  Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs
             with a similar chemical structure of HM61713

          -  Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that
             target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s)
             within 28 days prior to the first administration of study drug, radiotherapy

          -  Any non-study related significant surgical procedures within the past 28 days prior to
             the first administration of study drug

          -  Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain
             metastases

          -  History of any other malignancy

          -  Clinically significant uncontrolled condition(s)

          -  Active or chronic pancreatitis

          -  Anyone with cardiac abnormalities or history

          -  Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis

          -  Pregnant or breast feeding

          -  In the opinion of the investigator, the patient is an unsuitable candidate to receive
             HM61713
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Safety Issue:
Description:To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).

Secondary Outcome Measures

Measure:Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1
Time Frame:At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Safety Issue:
Description:To assess clinical efficacy of HM61713 regarding disease control rate (DCR).
Measure:Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death
Time Frame:At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Safety Issue:
Description:To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).
Measure:Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first
Time Frame:At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Safety Issue:
Description:To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).
Measure:Overall survival (OS), defined as the time from first administration of study drug until death from any cause
Time Frame:From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
Safety Issue:
Description:To assess clinical efficacy of HM61713 regarding Overall survival (OS).
Measure:Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1
Time Frame:At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Safety Issue:
Description:To assess clinical efficacy of HM61713 regarding Time to progression (TTP).
Measure:Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response
Time Frame:At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Safety Issue:
Description:To assess clinical efficacy of HM61713 regarding tumor shrinkage.
Measure:Peak concentration (Cmax) of HM61713
Time Frame:Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Safety Issue:
Description:To determine the pharmacokinetic (PK) profile of HM61713.
Measure:Trough plasma concentration (Ctrough) of HM61713
Time Frame:Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Safety Issue:
Description:To determine the pharmacokinetic (PK) profile of HM61713.
Measure:Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713
Time Frame:Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Safety Issue:
Description:To determine the pharmacokinetic (PK) profile of HM61713.
Measure:Patient reported outcomes (PROs)
Time Frame:At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
Safety Issue:
Description:To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.
Measure:ECG/QTc (absolute values and change from baseline)
Time Frame:Adverse events will be collected from baseline until 28 days after the last dose
Safety Issue:
Description:To evaluate the effect of HM61713 on the QT interval.
Measure:Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
Time Frame:Adverse events will be collected from baseline until 28 days after the last dose
Safety Issue:
Description:To assess the safety and tolerability of HM61713.
Measure:QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS.
Time Frame:Adverse events will be collected from baseline until 28 days after the last dose
Safety Issue:
Description:To assess the safety and tolerability of HM61713.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Hanmi Pharmaceutical Company Limited

Trial Keywords

  • NSCLC
  • EGFR-TKI
  • non small cell lung cancer
  • HM61713
  • T790M-positive
  • lung cancer
  • Phase II
  • Olmutinib

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