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

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT02485652

Run by

Hanmi Pharmaceutical Company Limited

People needed

162

Starts

2015-08-31

Expected to finish

2020-12-08

Last updated by the study team

2021-01-22

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Research Site — Bethesda, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Lebanon, New Hampshire, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Washington, Washington, United States
• Research Site — Darlinghurst, Australia
• Research site — Fitzroy, Australia
• Research Site — Frankston, Australia
• Research Site — Kogarah, Australia
• Research Site — St Albans, Australia
• Research Site — Woolloongabba, Australia
• Research Site — Toronto, Canada
• Research Site — Berlin, Germany
• Research Site — Homburg, Germany
• Research Site — Leipzig, Germany
• Research Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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