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Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy

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ClinicalTrials.gov Identifier: NCT02444819
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR mutation

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: HM61713 Phase 2

Detailed Description:
HM-EMSI-201 study targets NSCLC patients with EGFR mutations by HM61713 anticancer drug as the first-line therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-arm, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line Anticancer Agent in NSCLC Patients With EGFR Mutation
Study Start Date : March 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HM61713
Subjects who entered the study will be administered HM61713 800 mg per day.
Drug: HM61713
HM61713 will be administered to evaluate efficacy and safety of subjects.
Other Name: Olmutinib




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year ]
    To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year ]
    To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1

  2. Disease control rate [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year ]
    To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1

  3. overall survival [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year ]
    To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1

  4. Time to progression [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year ]
    To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1

  5. Maximum decrease in tumor size [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year ]
    To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1

  6. Quality of life questionnaire [ Time Frame: At baseline and every visit, expected average 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged at least 19 years at the time of signing informed consent
  • Cytologically or histologically confirmed, advanced or metastatic NSCLC which is not amenable to curative surgery (Stage IIIb or IV)
  • Documented EGFR mutations (excluding exon 20 insertion)
  • At least one lesion that can be used as a measurable lesion per RECIST version 1.1
  • Performance status under 1 per ECOG score
  • Life expectancy of at least 12 weeks
  • Adequate hematological and biological functions
  • Provide voluntary consent to participate the study and sign the written consent form

Exclusion Criteria:

  • Treatment of chemotherapy, biological therapy or immunotherapy for anticancer therapies of stage IIIb or IV NSCLC (excluding adjuvant/neoadjuvant chemotherapy, radiotherapy or radiochemotherapy prior to more than 6 months from the first dose of study treatment
  • History of treatment with an EGFR targeting small molecule or antibodies
  • Any non-study related significant surgical procedures requires general anesthesia or breathing apparatus within the past 4 weeks of the first dose of study treatment (excluding video-assisted thoracoscopic surgery or open-and-closed surgery prior to the past 2 weeks of the first dose of study treatment)
  • History of any other malignancy within 5 years of study participation (other than curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors unless it has been definitively treated with no evidence of relapse or recurrence within the past 3 years)
  • Clinically significant uncontrolled conditions of infectious disease including active infection that requires parenteral antibiotics (except when conditions are definitively treated or controlled)
  • Spinal cord compression, leptomeningeal carcinomatosis, symptomatic or uncontrolled brain metastasis
  • Presence or history of ILD or pulmonary fibrosis
  • NYHA class III or IV cardiac insufficiency, uncontrolled hypertension, experienced unstable angina pectoris or cardiac infarction within 6 months, uncontrolled cardiac arrhythmia or clinically significant abnormal cardiovascular activities
  • LVEF < 40%
  • Presence or history of pancreatitis or serum amylase > 1.5xULN
  • Inability to swallow the formulated product or gastrointestinal tract abnormalities which would preclude administration or absorption of study medication
  • Mental or congenital disabilities (e.g. dementia or epilepsy) which would preclude understanding of informed consent or following the study protocol
  • History of hypersensitivities to investigational drug or related similar class drugs
  • Pregnant or breast feeding
  • Unwillingness of adequate contraception during study treatment and at least 2 months after treatment
  • Unwillingness of following procedures of study protocol or follow-up assessments; Unable to follow up for long term for psychological, social, family problem or geographical reasons
  • History of treatment with other investigational drugs or investigational medical devices prior to 28 days of the first dose of study treatment
  • In the opinion of the investigator, the patient is an unsuitable candidate to the study
  • ECG finding of QTcF > 450 msec at rest

Information from the National Library of Medicine

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): NCT02444819


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Study Director: Yohan Kim, MD Hanmi Pharmaceutical Company Limited
Principal Investigator: Keunchil Park, MD PhD Samsung Medical Center
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02444819    
Other Study ID Numbers: HM-EMSI-201
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Keywords provided by Hanmi Pharmaceutical Company Limited:
HM61713
Epidermal Growth Factor Receptor mutation positive NSCLC
olmutinib
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases