Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy

NCT02444819 | Completed Phase 2

• 1 other identifier: HM-EMSI-201
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Keywords

HM61713; Epidermal Growth Factor Receptor mutation positive NSCLC; olmutinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-free survival

  At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

• Disease control rate

  At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

• overall survival

  At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

• Time to progression

  At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

• Maximum decrease in tumor size

  At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

Study Arms (1)

HM61713

EXPERIMENTAL

Subjects who entered the study will be administered HM61713 800 mg per day.

Drug: HM61713

Interventions

HM61713 DRUG

HM61713 will be administered to evaluate efficacy and safety of subjects.

Also known as: Olmutinib

HM61713

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

olmutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yohan Kim, MD

  Hanmi Pharmaceutical Company Limited

  STUDY DIRECTOR

• Keunchil Park, MD PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 15, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

KR (1)