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Phase I Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of HM61713 Tablet in NSCLC Patients With EGFR Mutation

Phase 1
20 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

Phase I Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of HM61713 Tablet in NSCLC Patients With EGFR Mutation

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

- To investigate biomarkers related to the safety and efficacy of HM61713.

Inclusion Criteria:

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
lung disease.

* 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.

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 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

Dose limiting Toxicity will be evaluated on Day 24 during Cycle 1

Safety Issue:


Principal Investigator

Dong-Wan Kim

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms