Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

Phase 2TerminatedNCT02485652

Hanmi Pharmaceutical Company Limited162 enrolled

Overview

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

162

Conditions

Non Small Cell Lung Cancer

Interventions

HM61713DRUG

800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: at least 20 years of age * Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy * Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI * At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q) * World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months * Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen * At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1 * Adequate hematological and biological function * Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug * Male patients should be documented to be sterile or agree to use barrier contraception * Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia Exclusion Criteria: * Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713 * Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy * Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug * Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases * History of any other malignancy * Clinically significant uncontrolled condition(s) * Active or chronic pancreatitis * Anyone with cardiac abnormalities or history * Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis * Pregnant or breast feeding * In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

Locations (72)

Outcomes

Primary Outcomes

Objective response rate (ORR)

To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).

Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months

Secondary Outcomes

Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1

To assess clinical efficacy of HM61713 regarding disease control rate (DCR).

Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months

Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death

To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).

Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months

Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first

To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).

Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months

Overall survival (OS), defined as the time from first administration of study drug until death from any cause

To assess clinical efficacy of HM61713 regarding Overall survival (OS).

Time frame: From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months

Data from ClinicalTrials.gov

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Research Site

Beverly Hills, California, United States

Research Site

Burbank, California, United States

Research Site 2

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Montebello, California, United States

Research Site

Orange, California, United States

Research Site

San Diego, California, United States

Research Site

Boca Raton, Florida, United States

Research Site

Honolulu, Hawaii, United States

Research Site

Evanston, Illinois, United States

...and 62 more locations