Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
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ClinicalTrials.gov Identifier: NCT02485652 |
Recruitment Status :
Terminated
(Study termination by the Sponsor)
First Posted : June 30, 2015
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Non Small Cell Lung Cancer | Drug: HM61713 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 31, 2015 |
Actual Primary Completion Date : | December 8, 2020 |
Actual Study Completion Date : | December 8, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
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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 Name: Olmutinib |
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485652

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 |
Responsible Party: | Hanmi Pharmaceutical Company Limited |
ClinicalTrials.gov Identifier: | NCT02485652 |
Other Study ID Numbers: |
HM-EMSI-202 2015-001435-21 ( EudraCT Number ) |
First Posted: | June 30, 2015 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | January 2021 |
NSCLC EGFR-TKI non small cell lung cancer HM61713 |
T790M-positive lung cancer Phase II Olmutinib |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |