Non Small Cell Lung Cancer Clinical Trial
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
Verified date | April 2018 |
Source | Hanmi Pharmaceutical Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 33 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1 | At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year | |
Secondary | Progression-free survival | To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1 | At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year | |
Secondary | Disease control rate | To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1 | At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year | |
Secondary | overall survival | To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1 | At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year | |
Secondary | Time to progression | To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1 | At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year | |
Secondary | Maximum decrease in tumor size | To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1 | At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year | |
Secondary | Quality of life questionnaire | At baseline and every visit, expected average 1 year |
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