Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in Non Small Cell Lung Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01588145
First received: April 26, 2012
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

The main objective of this study is to evaluate the safety and tolerability of HM61713 tablet.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: HM61713
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of HM61713 Tablet in NSCLC Patients With EGFR Mutation

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Dose limiting Toxicity will be evaluated on Day 24 during Cycle 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM61713
Dose: 50mg bid, 100mg bid, 150mg bid, 225mg bid,...
Drug: HM61713
BIDX21D/3W for HM61713 tablets

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 transplant
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588145

Contacts
Contact: Kyung-Mi Park kmpark@hanmi.co.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Dae-Ho Lee       leedaeho@amc.seoul.kr   
Principal Investigator: Dae-Ho Lee         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong-Wan Kim       kimdw@snu.ac.kr   
Principal Investigator: Dong-Wan Kim         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Dong-Wan Kim Seoul National University Hospital
Principal Investigator: Dae-Ho Lee Asan Medical Center
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01588145     History of Changes
Other Study ID Numbers: HM-EMSI-101
Study First Received: April 26, 2012
Last Updated: April 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014