Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients
Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Study Type
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: HM61713
Type: Drug
Overall Status
The main objective of this study is to evaluate the safety and tolerability of HM61713 tablet.
Detailed Description
Besides the main objective, there are 3 other objectives as follows:

- To evaluate the anti-cancer effect of HM61713 in Non Small Cell Lung Cancer (NSCLC) patients with EGFR mutation

- To investigate the pharmacokinetic profile of HM61713 and its metabolites after oral administration

- To investigate biomarkers related to the safety and efficacy of HM61713
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC

2. Patients with EGFR mutation-positive tumor

3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

4. Estimated life expectancy of at least 12 weeks

5. Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic [aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL] function. No significant heart and lung disease.

※ For subjects with a liver metastases, AST/ALT/ALP≤ 5 x ULN is allowed; and for subjects with bone marrow metastases, ALP≤ 5 x ULN is allowed

6. Patients with amylase level ≤ 1.5 x ULN

7. Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.

1. Malignancy that has progressed after at least two prior chemotherapy regimens, including epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)

2. 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.

1. Patients with disease progression despite anticancer therapy with EGFR-TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Disease progression is defined as progression confirmed during treatment or within 2 weeks after the last dose of treatment)

2. Patients who have provided voluntary consent for collection of tumor tissue taken and archived after the last anticancer therapy or collection of new tissue specimen and signed the written consent document

3. If previously treated with radiation therapy, surgery or hormone therapy as of screening, at least 2 weeks should have elapsed from the last regimen and any toxic effect of prior therapy should resolve to a Grade 1 or less

Exclusion Criteria:

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 been controlled).

2. Symptomatic or uncontrolled central nervous system metastases

3. Patients who had previously received, or is planning to receive, the bone marrow transplant

4. Patients with interstitial lung disease, including pulmonary fibrosis

5. Left ventricular ejection fraction (LVEF) < 40% or New York Heart Association (NYHA) Class III or IV heart failure

6. Patients with the history of pancreatitis

7. 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.

8. History, or current evidence, of any psychiatric or congenital disorder, including dementia or epilepsy, which might impair the patient's ability to understand or to comply with the requirements of the protocol or to provide informed consent

9. Patient with compromised organ function, which, in the investigator's opinion, could interfere with the subject's ongoing participation in the study (e.g., a history of infection or severe medical condition (e.g., allergy))

10. Pregnant or breast-feeding women, or women of child-bearing potential who do not use an appropriate method of contraception (male patients should also use an appropriate method of contraception during the study period)

11. Patients who had received other investigational product within 30 days prior to screening (except patients who had received investigational product of EGFR TKI in Expansion part)
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Kim - 82-2-2072-7376
Start Date
March 2012
Completion Date
December 2016
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Record processing date processed this data on July 28, 2015 page