Study Stopped
Study termination by the Sponsor
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
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
2 other identifiers
interventional
162
10 countries
72
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2015
Longer than P75 for phase_2
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedStudy Start
First participant enrolled
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2020
CompletedJanuary 22, 2021
January 1, 2021
5.3 years
June 22, 2015
January 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
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 Outcomes (13)
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
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
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
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
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
At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
- +8 more secondary outcomes
Study Arms (1)
HM61713
EXPERIMENTALHM61713 800 mg (2 x 400 mg tablets) once daily (QD)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Research Site
Beverly Hills, California, United States
Research Site
Burbank, California, United States
Research Site 2
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Montebello, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Evanston, Illinois, United States
Research Site
Bethesda, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Lebanon, New Hampshire, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Washington, Washington, United States
Research Site
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
Toronto, Canada
Research Site
Berlin, Germany
Research Site
Homburg, Germany
Research Site
Leipzig, Germany
Research Site
München, Germany
Research Site
Ulm, Germany
Research Site
Bergamo, Italy
Research Site
Bologna, Italy
Research Site
Catania, Italy
Research Site
Milan, Italy
Research Site
Rome, Italy
Research Site
George Town, Pulau Pinang, Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Kuantan, Malaysia
Research Site
Kuching, Malaysia
Research Site
Makati, Kalakhang Maynila, Philippines
Research Site
Pasig, Manila, Philippines
Research Site 2
Manila, National Capital Region, Philippines
Research Site
Manila, National Capital Region, Philippines
Research Site
Cebu, Philippines
Research Site
Cheongju-si, South Korea
Research Site
Goyang-si, South Korea
Research Site
Hwasun, South Korea
Research Site
Incheon, South Korea
Research Site 2
Seongnam-si, South Korea
Research Site
Seongnam-si, South Korea
Research Site 2
Seoul, South Korea
Research Site 3
Seoul, South Korea
Research Site 4
Seoul, South Korea
Research Site 5
Seoul, South Korea
Research Site 6
Seoul, South Korea
Research Site 7
Seoul, South Korea
Research Site 8
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
A Coruña, Spain
Research Site 2
Barcelona, Spain
Research Site 3
Barcelona, Spain
Research Site 4
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Donostia / San Sebastian, Spain
Research Site 2
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Navarra, Spain
Research Site 2
Valencia, Spain
Research Site
Valencia, Spain
Research Site
Kaohsiung City, Taiwan
Research Site
Taichung, Taiwan
Research Site 2
Tainan, Taiwan
Research Site
Tainan, Taiwan
Research Site 2
Taipei, Taiwan
Research Site
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 30, 2015
Study Start
August 31, 2015
Primary Completion
December 8, 2020
Study Completion
December 8, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01