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

January 17, 2021 updated by: Hanmi Pharmaceutical Company Limited

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

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

  • Australia
      • Darlinghurst, Australia
        • Research Site
      • Fitzroy, Australia
        • Research Site
      • Frankston, Australia
        • Research Site
      • Kogarah, Australia
        • Research Site
      • St Albans, Australia
        • Research Site
      • Woolloongabba, Australia
        • Research Site
  • Canada
      • Toronto, Canada
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Homburg, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
  • Italy
      • Bergamo, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Rome, Italy
        • Research Site
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Research Site
      • Goyang-si, Korea, Republic of
        • Research Site
      • Hwasun, Korea, Republic of
        • Research Site
      • Incheon, Korea, Republic of
        • Research Site
      • Seongnam-si, Korea, Republic of
        • Research Site 2
      • Seongnam-si, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site 2
      • Seoul, Korea, Republic of
        • Research Site 3
      • Seoul, Korea, Republic of
        • Research Site 4
      • Seoul, Korea, Republic of
        • Research Site 5
      • Seoul, Korea, Republic of
        • Research Site 6
      • Seoul, Korea, Republic of
        • Research Site 7
      • Seoul, Korea, Republic of
        • Research Site 8
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Kuantan, Malaysia
        • Research Site
      • Kuching, Malaysia
        • Research Site
    • Penang
      • George Town, Penang, Malaysia
        • Research Site
  • Philippines
      • Cebu, Philippines
        • Research Site
    • Kalakhang Maynila
      • Makati, Kalakhang Maynila, Philippines
        • Research Site
    • Manila
      • Pasig, Manila, Philippines
        • Research Site
    • Metro Manila
      • Manila, Metro Manila, Philippines
        • Research Site 2
      • Manila, Metro Manila, Philippines
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site 2
      • Barcelona, Spain
        • Research Site 3
      • Barcelona, Spain
        • Research Site 4
      • La Coruna, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Madrid, Spain
        • Research Site 2
      • Navarra, Spain
        • Research Site
      • San Sebastian, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Valencia, Spain
        • Research Site 2
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site 2
      • Taipei, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site 2
  • United States
    • California
      • Beverly Hills, California, United States
        • Research Site
      • Burbank, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site 2
      • Montebello, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Illinois
      • Evanston, Illinois, United States
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
    • Washington
      • Washington, Washington, United States
        • Research Site

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
Drug: HM61713
800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.
Other Names:
  • Olmutinib

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To assess clinical efficacy of HM61713 regarding disease control rate (DCR).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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
To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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
To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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
To assess clinical efficacy of HM61713 regarding Overall survival (OS).
From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
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
To assess clinical efficacy of HM61713 regarding Time to progression (TTP).
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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
To assess clinical efficacy of HM61713 regarding tumor shrinkage.
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
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)
To determine the pharmacokinetic (PK) profile of HM61713.
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)
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)
To determine the pharmacokinetic (PK) profile of HM61713.
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)
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)
To determine the pharmacokinetic (PK) profile of HM61713.
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)
Patient reported outcomes (PROs)
Time Frame: At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.
At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
ECG/QTc (absolute values and change from baseline)
Time Frame: Adverse events will be collected from baseline until 28 days after the last dose
To evaluate the effect of HM61713 on the QT interval.
Adverse events will be collected from baseline until 28 days after the last dose
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
To assess the safety and tolerability of HM61713.
Adverse events will be collected from baseline until 28 days after the last dose
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
To assess the safety and tolerability of HM61713.
Adverse events will be collected from baseline until 28 days after the last dose

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Keunchil Park, M.D., Ph.D, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
  • Principal Investigator: Pasi A. Jänne, M.D., Ph.D, Dana-Farber Cancer Institute, Boston, MA, USA

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)

August 31, 2015

Primary Completion (Actual)

December 8, 2020

Study Completion (Actual)

December 8, 2020

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-EMSI-202
  • 2015-001435-21 (EudraCT Number)

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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