Phase I Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of HM61713 Tablet in NSCLC Patients With EGFR Mutation
1. Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC
2. Patients with EGFR mutation-positive tumor
3. Malignancy that has progressed after at least two prior chemotherapy regimens,
including EGFR TKI (epidermal growth factor receptor tyrosine kinase inhibitors)
4. If previously treated with other chemotherapy, radiation therapy, surgery or hormone
therapy, at least 2 weeks should have elapsed from the last regimen prior to study
entry. (if the last regimen includes mitomycin, at least 6 weeks should elapse), and
any toxic effect of prior therapy should resolve to a Grade 1 or less.
5. Patients must be 20 years of age or older
6. Patients must have an ECOG performance status of 2 or less
7. Estimated life expectancy of at least 12 weeks
8. Subjects with adequate bone marrow (WBC ≥ 4,000/mm3, Platelet ≥ 100,000/mm3,
Hemoglobin ≥ 9.0g/dL, ANC ≥ 1,500/mm3), renal (Creatinine ≤ 1.5mg/dl) and hepatic
(AST/ALT/ALP ≤ 3xULN, Total bilirubin ≤ 2.0mg/dL) function. No significant heart and
* For subjects with a liver metastases, AST/ALT/ALP ≤ 5xULN is allowed; and for
subjects with bone marrow metastases, ALP ≤ 5xULN is allowed
9. Subjects who have provided voluntary consent to participate in the study, and signed
the written consent document.
1. Hematologic malignancies such as leukemia or uncontrolled infectious/neurological
disease (a patient with an active bacterial infection requiring treatment with
parenteral antibiotics are excluded; however, the patient may be eligible if the
infection has completely resolved or controlled).
2. Symptomatic or uncontrolled central nervous system metastases
3. Patients who had previously received, or is planning to receive, the bone marrow
4. Patients with parenchymal lung disease, including pulmonary fibrosis
5. LVEF (left ventricular ejection fraction) < 40% or NYHA (New York Heart Association)
Class III or IV heart failure
6. Patients who are unable to take tablets orally or have a clinically significant
gastrointestinal disorder, which may interfere with administration, metabolism and
absorption of the investigational drug.