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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02485652




Registration number
NCT02485652
Ethics application status
Date submitted
22/06/2015
Date registered
30/06/2015
Date last updated
12/03/2018

Titles & IDs
Public title
Phase II Trial of HM61713 for the Treatment of =2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
Scientific 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
Secondary ID [1] 0 0
2015-001435-21
Secondary ID [2] 0 0
HM-EMSI-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HM61713

Experimental: HM61713 - HM61713 800 mg (2 x 400 mg tablets) once daily (QD)


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) - To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).
Timepoint [1] 0 0
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcome [1] 0 0
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 - To assess clinical efficacy of HM61713 regarding disease control rate (DCR).
Timepoint [1] 0 0
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcome [2] 0 0
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 - To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).
Timepoint [2] 0 0
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcome [3] 0 0
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 - To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).
Timepoint [3] 0 0
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcome [4] 0 0
Overall survival (OS), defined as the time from first administration of study drug until death from any cause - To assess clinical efficacy of HM61713 regarding Overall survival (OS).
Timepoint [4] 0 0
From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
Secondary outcome [5] 0 0
Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 - To assess clinical efficacy of HM61713 regarding Time to progression (TTP).
Timepoint [5] 0 0
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcome [6] 0 0
Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response - To assess clinical efficacy of HM61713 regarding tumor shrinkage.
Timepoint [6] 0 0
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcome [7] 0 0
Peak concentration (Cmax) of HM61713 - To determine the pharmacokinetic (PK) profile of HM61713.
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
Trough plasma concentration (Ctrough) of HM61713 - To determine the pharmacokinetic (PK) profile of HM61713.
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713 - To determine the pharmacokinetic (PK) profile of HM61713.
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Patient reported outcomes (PROs) - To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.
Timepoint [10] 0 0
At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
Secondary outcome [11] 0 0
ECG/QTc (absolute values and change from baseline) - To evaluate the effect of HM61713 on the QT interval.
Timepoint [11] 0 0
Adverse events will be collected from baseline until 28 days after the last dose
Secondary outcome [12] 0 0
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). - To assess the safety and tolerability of HM61713.
Timepoint [12] 0 0
Adverse events will be collected from baseline until 28 days after the last dose
Secondary outcome [13] 0 0
QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS. - To assess the safety and tolerability of HM61713.
Timepoint [13] 0 0
Adverse events will be collected from baseline until 28 days after the last dose

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research site - Fitzroy
Recruitment hospital [3] 0 0
Research Site - Frankston
Recruitment hospital [4] 0 0
Research Site - Kogarah
Recruitment hospital [5] 0 0
Research Site - St Albans
Recruitment hospital [6] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- St Albans
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Canada
State/province [10] 0 0
Toronto
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Homburg
Country [13] 0 0
Germany
State/province [13] 0 0
Leipzig
Country [14] 0 0
Germany
State/province [14] 0 0
München
Country [15] 0 0
Germany
State/province [15] 0 0
Ulm
Country [16] 0 0
Italy
State/province [16] 0 0
Bergamo
Country [17] 0 0
Italy
State/province [17] 0 0
Bologna
Country [18] 0 0
Italy
State/province [18] 0 0
Catania
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Rome
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Cheongju-si
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Goyang-si
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Hwasun
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Incheon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seongnam-si
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Malaysia
State/province [27] 0 0
Penang
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur
Country [29] 0 0
Malaysia
State/province [29] 0 0
Kuantan
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuching
Country [31] 0 0
Philippines
State/province [31] 0 0
Kalakhang Maynila
Country [32] 0 0
Philippines
State/province [32] 0 0
Manila
Country [33] 0 0
Philippines
State/province [33] 0 0
Metro Manila
Country [34] 0 0
Philippines
State/province [34] 0 0
Cebu
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Navarra
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Spain
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San Sebastian
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Spain
State/province [40] 0 0
Valencia
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Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
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Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hanmi Pharmaceutical Company Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02485652
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keunchil Park, M.D., Ph.D
Address 0 0
Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02485652